Historical Information about Device Emergency Use Authorizations
This page is intended to provide reference information on EUAs that were previously issued, including revoked EUAs.
On this page:
- Infusion Pumps
- In Vitro Diagnostics (IVD)
- Personal Protective Equipment (PPE)
- Decontamination Systems for PPE
Infusion Pumps
Test | Date** | Letter of Authorization |
Fact Sheet for Healthcare Providers |
Fact Sheet for Patients |
Labeling (PDF) |
---|---|---|---|---|---|
Umbrella of Infusion Pumps and Infusion Pump Accessories On September 21, 2020, FDA has determined that circumstances support revocation of the umbrella EUA to protect the public health or safety. Individual EUAs will allow for tailored indications and scopes of authorization, including but not limited to those for different environments of use, routes of administration, and patient populations. In addition, this would allow for individualized conditions of authorization to address any issue unique to a specific device, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA. Accordingly, FDA has decided to revoke this EUA. Instead, FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria. Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act. |
05/13/2020 09/21/2020 |
[Authorization] | [Healthcare] | [Patients] |
In Vitro Diagnostics (IVD)
Test | Date** | Letter of Authorization |
Fact Sheet for Healthcare Providers |
Fact Sheet for Patients |
Labeling (PDF) |
---|---|---|---|---|---|
Omni COVID-19 Assay by RT-PCR In a request to the FDA received February 7, 2022, Omnipathology Solutions Medical Corporation requested that the FDA Emergency Use Authorization (EUA200170) for the Omni COVID-19 Assay by RT-PCR issued on June 17, 2020 and amended on December 28, 2020 and September 23, 2021, be revoked. Omnipathology Solutions Medical Corporation confirmed that due to discontinuation of the commercial primer and probe products used in the Omni COVID-19 Assay by RT-PCR it has decided to discontinue use of this test but continue to offer COVID-19 testing using another FDA EUA-authorized test. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on February 14, 2022 the FDA revoked the EUA for emergency use of Omnipathology Solutions Medical Corporation’s Omni COVID-19 Assay by RT-PCR, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
06/17/2020 12/28/2020 09/23/2021 02/14/2022 |
[Healthcare] | [Patients] | [EUA Summary] | |
LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel In a request to the FDA received January 6, 2022, LifeHope Labs requested that the FDA Emergency Use Authorization (EUA200796) for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel issued on June 29, 2020 and revised on September 23, 2021, be discontinued. LifeHope Labs confirmed that it is no longer using the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, having transitioned to another FDA EUA-authorized test. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on February 7, 2022 the FDA revoked the EUA for emergency use of LifeHope Labs LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
06/29/2020 09/23/2021 02/07/2022 |
[Healthcare] | [Patients] | [EUA Summary] | |
MosaiQ COVID-19 Antibody Magazine (Quotient Suisse SA) In a request to the FDA received December 22, 2021, Quotient Suisse SA requested that the FDA Emergency Use Authorization (EUA201083) for the MosaiQ COVID-19 Antibody Magazine issued on September 25, 2020 be terminated. Quotient Suisse SA decided not to continue to commercially support the MosaiQ COVID-19 Antibody Magazine. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on January 11, 2022 the FDA revoked the EUA for emergency use of Quotient Suisse SA’s MosaiQ COVID-19 Antibody Magazine, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
09/25/2020 04/27/2021 09/23/2021 01/11/2022 |
[Healthcare] | [Recipients] | [IFU] | |
BioPlex 2200 SARS-CoV-2 IgG (Bio-Rad Laboratories) In a request to the FDA received December 20, 2021, Bio-Rad Laboratories requested that the FDA Emergency Use Authorization (EUA202689) for the BioPlex 2200 SARS-CoV-2 IgG issued on July 1, 2021 be revoked. The BioPlex 2200 SARS-CoV-2 IgG Panel has not been commercialized by Bio-Rad in the U.S. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on January 11, 2022 the FDA revoked the EUA for emergency use of Bio-Rad Laboratories BioPlex 2200 SARS-CoV-2 IgG, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
07/01/2021 09/23/2021 01/11/2022 |
[Healthcare] | [Recipients] | [IFU] | |
Xpert Omni SARS-CoV-2 In a request to the FDA received December 17, 2021, Cepheid requested that the FDA Emergency Use Authorization (EUA202699) for the Xpert Omni SARS-CoV-2 issued on November 27, 2020 be revoked. Cepheid indicated that due to the current public clinical needs being met by Cepheid’s other EUA tests that are available, Cepheid has not commercially distributed any of the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on December 20, 2021, the FDA revoked the EUA for emergency use of Cepheid’s Xpert Omni SARS-CoV-2, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
11/27/2020 12/23/2020 04/20/2021 09/23/2021 12/20/2021 |
[Healthcare] | [Patients] | [IFU] | |
ADVIA Centaur SARS-CoV-2 IgG (COV2G) In a request to the FDA received December 9, 2021, Siemens Healthcare Diagnostics Inc. (Siemens) requested that the FDA Emergency Use Authorization (EUA201697) for the ADVIA Centaur SARS-CoV-2 IgG (COV2G) issued on July 31, 2020 be removed from FDA’s list of authorized devices. FDA understands that the authorized product is no longer being marketed. Accordingly, on December 17, 2021, the FDA revoked the EUA for emergency use of Siemens ADVIA Centaur SARS-CoV-2 IgG (COV2G), pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
07/31/2020 09/23/2021 12/17/2021 |
[Healthcare] | [Recipients] | [IFU] | |
Atellica IM SARS-CoV-2 IgG (COV2G) In a request to the FDA received December 9, 2021, Siemens Healthcare Diagnostics Inc. (Siemens) requested that the FDA Emergency Use Authorization (EUA201696) for the Atellica IM SARS-CoV-2 IgG (COV2G) issued on July 31, 2020 be removed from FDA’s list of authorized devices. FDA understands that the authorized product is no longer being marketed. Accordingly, on December 17, 2021, the FDA revoked the EUA for emergency use of Siemens Atellica IM SARS-CoV-2 IgG (COV2G), pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
07/31/2020 09/23/2021 12/17/2021 |
[Healthcare] | [Recipients] | [IFU] | |
SARS-COV-2 R-GENE In a request to the FDA received December 10, 2021, BioMérieux SA requested that the FDA Emergency Use Authorization (EUA200445) for the SARS-COV-2 R-GENE issued on May 6, 2020 be revoked. BioMérieux SA indicated that due to the current public clinical needs being met by other EUA assays that are available on the market, BioMérieux SA has decided to no longer commercially support the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on December 17, 2021, the FDA revoked the EUA for emergency use of BioMérieux SA’s SARS-COV-2 R-GENE, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
05/06/2020 11/06/2020 09/23/2021 12/17/2021 |
[Healthcare] | [Patients] | [IFU] | |
qSARS-CoV-2 IgG/IgM Rapid Test In a request to the FDA received December 7, 2021, Cellex Inc. requested that the FDA withdraw the Emergency Use Authorization (EUA200058) for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test issued on April 1, 2020. FDA understands that the product is no longer being distributed. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on December 10, 2021, the FDA revoked the EUA for emergency use of Cellex Inc.’s q-SARS-CoV-2 IgG/IgM Rapid Test, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
04/01/2020 06/12/2020 09/23/2020 12/10/2021 |
[Healthcare] | [Patients] | [IFU] | |
BMC-CReM COVID-19 Test In a request to the FDA received October 4, 2021, and reconfirmed December 6, 2021, Boston Medical Center requested that the EUA for the BMC-CReM COVID-19 Test issued on July 10, 2020, be revoked. Boston Medical Center confirmed that the BMC-CReM COVID-19 Test is no longer performed pursuant to the EUA. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on December 8, 2021, the FDA revoked the EUA for emergency use of Boston Medical Center’s BMC-CReM COVID-19 Test, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
07/10/2020 09/25/2020 09/23/2021 12/08/2021 (revoked) |
[Healthcare] | [Patients] | [EUA Summary] | |
Akron Children's Hospital SARS-CoV-2 Assay In a request to the FDA received December 3, 2021, Akron Children’s Hospital requested that the EUA for the Akron Children's Hospital SARS-CoV-2 Assay issued on September 29, 2020, be revoked. Akron Children’s Hospital confirmed that it stopped performing the Akron Children’s Hospital SARS-CoV-2 Assay, having implemented a number of additional SARS-CoV-2 molecular assays which have received EUA. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on December 8, 2021, the FDA revoked the EUA for emergency use of Akron Children's Hospital’s Akron Children's Hospital SARS-CoV-2 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
09/29/2020 09/23/2021 12/08/2021 |
[Healthcare] | [Patients] | [EUA Summary] | |
BioGX SARS-CoV-2 Reagents for BD MAX System In a request to the FDA received December 3, 2021, Becton, Dickinson & Company’s (BD’s) requested that the EUA for the BioGX SARS-CoV-2 Reagents for BD MAX System issued on April 2, 2020, be revoked. BD indicated that to simplify and focus their BD MAX Portfolio, BD made the decision to discontinue the sale of the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on December 8, 2021, the FDA revoked the EUA for emergency use of BD’s BioGX SARS-CoV-2 Reagents for BD MAX System, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
04/02/2020 04/07/2020 05/29/2020 09/25/2020 09/23/2021 12/08/2021 |
[Healthcare] | [Patients] | [IFU] | |
TaqPath COVID-19 MS2 Combo Kit 2.0. In a letter to the FDA dated September 22, 2021, Thermo Fisher Scientific, Inc., on behalf of Life Technologies Corporation (a part of Thermo Fisher Scientific, Inc.), requested that the EUA for the TaqPath COVID-19 MS2 Combo Kit 2.0 issued on August 2, 2021, be revoked. Thermo Fisher Scientific Inc. indicated that it has decided to not commercially support the TaqPath COVID-19 MS2 Combo Kit 2.0 at this time. As a result, these circumstances make revocation appropriate to protect the public health or safety. |
08/02/2021 09/27/2021 |
[Authorization] | [Healthcare] | [Patients] | [IFU] |
Guardant-19 In a letter to the FDA dated August 2, 2021, Guardant Health Inc. requested that the EUA for the Guardant-19 test issued on August 21, 2020 and amended on December 28, 2020, be revoked. Guardant Health Inc. requested revocation of the Guardant-19 test effective July 16, 2021. As a result, these circumstances make revocation appropriate to protect the public health or safety. |
08/21/2020 08/06/2021 |
[Authorization] | [Healthcare] | [Patients] | [EUA Summary] |
MatMaCorp COVID-19 2SF Test In a letter to the FDA dated July 29, 2021, Materials and Machines Corporation of America (DBA MatMaCorp, Inc.) requested that the EUA for the MatMaCorp COVID-19 2SF Test issued on December 17, 2020, be revoked. MatMaCorp, Inc. notified FDA that it will no longer be distributing the MatMaCorp COVID-19 2SF Test as of July 31, 2021. As a result, these circumstances make revocation appropriate to protect the public health or safety. |
12/17/2020 (issued) 08/03/2021 (revoked) |
[Authorization] | [Healthcare] | [Patients] | [IFU] |
Gravity Diagnostics COVID-19 Assay In an email request originally received March 11, 2021, and reconfirmed July 12, 2021, Gravity Diagnostics, LLC. requested that the EUA for the Gravity Diagnostics COVID-19 Assay issued on June 1, 2020, and amended on June 30, 2020, and September 21, 2020, be revoked. Gravity Diagnostics, LLC confirmed that it is no longer using the Gravity Diagnostics COVID-19 Assay at Gravity’s laboratory, having transitioned to another EUA-authorized test. As a result, these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on July 21, 2021, the FDA revoked the EUA for emergency use of Gravity Diagnostics, LLC’s Gravity Diagnostics COVID-19 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act. |
06/01/2020 07/21/2021 |
[Authorization] [Amendment] |
[Healthcare] | [Patients] | [EUA Summary] |
Curative (formerly Curative-Korva) SARS-Cov-2 Assay In a letter to the FDA dated June 16, 2021, Curative Inc. requested that the EUA for the Curative SARS-Cov-2 Assay issued on April 16, 2020 under the original name Curative-Korva SARS-Cov-2 Assay, and amended on June 11, 2020, be revoked effective July 15, 2021. Curative stated that it was transitioning to the use of different EUA-authorized SARS-CoV-2 tests for the testing offered at its laboratories. As a result, the Curative test will no longer be used, and these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on July 15, 2021, the FDA revoked the EUA for emergency use of Curative Inc.’s Curative SARS-Cov-2 Assay (originally authorized as KorvaLabs Inc.’s Curative-Korva SARS-Cov-2 Assay), pursuant to section 564(g)(2)(C) of the Act. |
04/16/2020 (issued) 07/15/2021 (revoked) |
[Authorization] [Amendment] |
[Healthcare] | [Patients] | [EUA Summary] |
BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC) The FDA issued a De Novo classification order for BioFire Diagnostics, BioFire Respiratory Panel 2.1 (RP2.1) as a Class II device under the generic name "Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test" (to be codified in 21 CFR 866.3981) on March 17, 2021. FDA has concluded that this is an adequate, approved, and available alternative for the BioFire Diagnostics, LLC device which was initially authorized for emergency use in 2020. Accordingly, on March 17, 2021, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for the BioFire Respiratory Panel 2.1 (RP2.1), issued on May 1, 2020, and revised on December 22, 2020, pursuant to section 564(g)(2) of the Act. |
12/22/2020 03/17/2021 |
[Authorization] [Amendment] |
[Healthcare] | [Patients] | [Labeling] |
Anti-SARS-CoV-2 Rapid Test (Autobio Diagnostics Co. Ltd.) On August 6, 2020, based on FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act. |
04/24/2020 (issued) 08/06/2020 (revoked) |
[Authorization] | [Healthcare] | [Recipients] | [Labeling] |
DPP COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.) On June 16, 2020, FDA revoked the EUA for emergency use of Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System, which was authorized to detect IgM and IgG antibodies against SARS-CoV-2 in serum and plasma (EDTA or lithium heparin), venous whole blood, or fingerstick whole blood specimens. New information from multiple evaluations of the device's clinical performance were reviewed following authorization and data from these evaluations demonstrated poor clinical performance of the device. Given the poor performance, after consideration of the totality of scientific evidence available to the Agency, FDA determined under section 564(g)(2)(B) that the criteria for issuance of emergency authorization in section 564(c) of the Act were longer met for the DPP COVID-19 IgM/IgG System. Specifically, given the poor device performance, FDA concluded that it was not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh its known and potential risks. In addition, based on the same information and the risks to public health from false test results, FDA concluded that revocation is appropriate to protect the public health or safety under section 564(g)(2)(C). |
04/14/2020 (issued) 06/16/2020 (revoked) |
[Authorization] | [Healthcare] | [Patients] | [Labeling] |
DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.) Chembio Diagnostic Systems, Inc.'s ("Chembio") DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name "Zika virus serological reagents," on June 3, 2020. FDA has concluded "that this is an adequate, approved, and available alternative for the Chembio device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act". In the context of section 564, the term "approved" refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of the Public Health Service Act. See section 564(a)(2) of the FD&C Act. Accordingly, on June 3, 2020, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for DPP Zika IgM Assay System, issued on September 27, 2017, and amended on February 6, 2018, and August 3, 2018, pursuant to section 564(g)(2) of the Act. |
08/03/18 |
[Authorization] |
[Healthcare] | [Patients] | [Labeling] |
ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.) Siemens Healthcare Diagnostics Inc.'s ("Siemens") ADVIA Centaur Zika test (K191578) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name "Zika virus serological reagents," on July 17, 2019. FDA has concluded "that this is an adequate, approved, and available alternative for the Siemens device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act". In the context of section 564, the term "approved" refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of the Public Health Service Act. See section 564(a)(2) of the FD&C Act. Accordingly, on July 17, 2019, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for ADVIA Centaur Zika test, issued on September 18, 2017, and amended on November 16, 2017, and April 18, 2019, pursuant to section 564(g)(2) of the Act. |
04/18/19 | [Authorization] [Amendment] [Amendment] |
[Healthcare] | [Patients] | [Labeling] |
ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.) FDA granted the De Novo classification request for InBios International, Inc.'s ("InBios") ZIKV Detect 2.0 IgM Capture ELISA, and established a new classification regulation for Zika virus serological reagents (class II) in 21 CFR 866.3935 on May 23, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the InBios device which was initially authorized for emergency use in 2016. Accordingly, on May 23, 2019, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for ZIKV Detect 2.0 IgM Capture ELISA, issued on August 17, 2016, and amended on March 27, 2017, and May 18, 2018, pursuant to section 564(g)(2) of the Act. |
05/18/18 | [Authorization] [Amendment] [Amendment] |
[Healthcare] | [Patients] | [Labeling] |
xMAP MultiFLEX Zika RNA Assay (Luminex Corporation) In a letter to FDA dated June 18, 2019, Luminex Corporation requested that the EUA for the xMAP MultiFLEX Zika RNA Assay issued on August 4, 2016, and amended on January 7, 2017, and May 19, 2017, be withdrawn. Luminex has decided to discontinue manufacture of the product and there is no remaining viable inventory of the xMAP MultiFLEX Zika RNA Assay. As a result, this product will no longer be marketed, and these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on July 3, 2019, FDA revoked the EUA for xMAP MultiFLEX Zika RNA Assay, pursuant to section 564(g)(2) of the Act. As of July 3, 2019, the xMAP MultiFLEX Zika RNA Assay that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA. |
05/19/17 | [Authorization] [Amendment] [Amendment] | [Healthcare] | [Patients] | [Labeling] |
LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated) DiaSorin Inc.'s ("DiaSorin's") LIAISON XL Zika Capture IgM II assay (K192046) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name "Zika virus serological reagents," on October 28, 2019. FDA has concluded that this is an adequate, approved, and available alternative for DiaSorin's device which was initially authorized for emergency use in 2017, for purposes of section 564(c)(3) of the Federal Food, Drug and Cosmetic Act (the Act)". As used in section 564(c)(3), the term "approved" refers to a product that is approved, authorized, licensed, or cleared under section 505, 510(k), 513, or 515 of the Act or section 351 of the Public Health Service Act. Accordingly, on October 28, 2019, FDA determined that the criteria for issuance of the Emergency Use Authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for LIAISON XL Zika Capture IgM II assay, issued on April 5, 2017, and amended on November 6, 2017, and December 27, 2018, pursuant to section 564(g)(2) of the Act. |
04/05/17 | [Authorization] [Amendment] [Amendment] |
[Healthcare] | [Patients] | [Labeling] |
ReEBOV Antigen Rapid Test (Zalgen Labs, LLC) On May 18, 2018, FDA revoked the EUA for emergency use of the ReEBOV Antigen Rapid Test, which was authorized by FDA for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood, and plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). On February 24, 2015, based on a request by Corgenix Inc. ("Corgenix"), FDA issued a letter authorizing the emergency use of this test. On November 3, 2016, FDA reissued the EUA to allow Zalgen Labs, LLC ("Zalgen") (and its authorized distributors) to distribute the ReEBOV Antigen Rapid Test manufactured by Corgenix, as well as distribute the ReEBOV Antigen Rapid Test manufactured by Zalgen if it met certain conditions, including that FDA concur after receiving performance characteristics for the Zalgen manufactured ReEBOV Antigen Rapid Test. In a letter to FDA dated March 1, 2018, Zalgen requested to FDA that the transfer of the EUA from Corgenix be withdrawn. In addition, there is no remaining viable inventory of the ReEBOV Antigen Rapid Test manufactured by Corgenix. As a result, this product will no longer be made available. These circumstances make revocation of the EUA appropriate to protect the public health or safety. |
11/03/16 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
LightMix® Zika rRT-PCR Test (Roche Molecular Systems, Inc.) In response to Roche Molecular Systems Inc.'s request dated March 10, 2017 to withdraw the LightMix® Zika rRT-PCR Test due to technical performance and business considerations, on March 13, 2017 FDA revoked the EUA for emergency use of the LightMix® Zika rRT-PCR Test. As of March 13, 2017, the LightMix® Zika rRT-PCR Test that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA. |
08/26/16 | [Authorization] [Amendment] |
[Healthcare] | [Patients] | [Labeling] |
OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.) FDA granted the De Novo classification request for OraSure Technologies Inc.'s ("OraSure's") OraQuick Ebola Rapid Antigen Test, and established a new classification regulation for "Device to detect antigens of biothreat microbial agents in human clinical specimens" (class II) in 21 CFR 866.4002 on October 10, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the OraSure devices which were initially authorized for emergency use in 2015, for use with whole blood specimens and 2016, for cadaveric oral fluid. Accordingly, on October 10, 2019, FDA determined that the criteria for issuance of both emergency use authorizations (EUAs) under section 564(c) of the Federal Food, Drug and Cosmetic Act (the Act) are no longer met and revoked the EUAs for: (1) OraQuick Ebola Rapid Antigen Test for use with whole blood specimens issued on July 31, 2015, and amended on March 18, 2016, and January 30, 2019, and (2) OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid issued on March 4, 2016, and amended on November 14, 2016, and February 1, 2019, pursuant to section 564(g)(2) of the Act. |
03/04/16 (Cadaver) |
[Authorization] [Amendment] |
[Response Team] |
[Relatives and Caregivers] |
[Labeling] |
07/31/15 (Blood) |
[Authorization] [Amendment] |
[Healthcare] | [Patients] | [Labeling] | |
ReEBOV™ Antigen Rapid Test (Corgenix Inc.) | 03/16/15 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
ReEBOV™ Antigen Rapid Test | 02/24/15 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
RealStar® Ebolavirus RT-PCR Kit 1.0 | 11/10/14 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
BioFire Defense LLC FilmArray NGDS BT-E Assay | 10/25/14 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
CDC Ebola Virus NP Real-time RT-PCR Assay | 10/10/14 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
CDC Ebola Virus VP40 Real-time RT-PCR Assay | 10/10/14 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
DoD EZ1 Real-time RT-PCR Assay (Ebola) | 08/05/14 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
IQuum Liat™ Influenza A/2009 H1N1 Assay | 05/04/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay | 03/23/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx | 03/22/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit | 03/11/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit | 02/16/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test | 02/01/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR | 01/21/10 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection | 12/24/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument | 12/18/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
CDC Swine Influenza Virus Real-time RT-PCR Detection Panel | 12/18/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR | 12/18/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test | 12/18/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
TessArray Resequencing Influenza A Microarray Detection Panel | 12/16/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
GeneSTAT 2009 A/H1N1 Influenza Test | 12/09/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Roche RealTime ready Influenza A/H1N1 Test | 11/13/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection | 10/27/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
Diatherix 2009 H1N1 Test | 10/09/09 | [Authorization] | [Healthcare] | [Patients] | [Labeling] |
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents | 05/02/09 | [Authorization] | [Healthcare] | [Patients] |
[Labeling] |
Personal Protective Equipment (PPE)
Personal Protective Equipment | Date* | Letter of Authorization |
Other Documents |
---|---|---|---|
Protective Barrier Enclosures | 05/01/2020 (Issued) 08/20/2020 (Revoked) |
[Authorization] | [Fact Sheet for Healthcare Providers] [Fact Sheet for Patients] |
Disposable N95 Respirators from Strategic National Stockpile | 05/01/2009 | [Fact Sheet] | |
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece |
04/03/2020 (Issued) 05/07/2020; 06/30/2021 (Revoked, |
[Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China] (Updated February 18, 2021) |
|
Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) |
03/24/2020 (Issued) 03/28/2020; 06/30/2021 (Revoked, |
[Exhibit 1: Authorized Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators] (Updated March 8, 2021) |
*Note that Secretary's determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
** Date of Authorization or of Latest Amendment
Decontamination Systems for Personal Protective Equipment
In a request to the FDA received December 3, 2021, Becton, Dickinson & Company’s (BD’s) requested that the EUA for the BioGX SARS-CoV-2 Reagents for BD MAX System issued on April 2, 2020, be revoked. BD indicated that to simplify and focus their BD MAX Portfolio, BD made the decision to discontinue the sale of the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety.