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  1. Coronavirus (COVID-19) and Medical Devices

FAQs on Viral Transport Media During COVID-19

This page provides answers to frequently asked questions relating to the development and use of transport media during the COVID-19 public health emergency. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.

This page includes questions and answers regarding the policies outlined in the Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

On this page, this guidance is referred to as the COVID-19 Transport Media Policy.

For information regarding the development and performance of tests for SARS-CoV-2, please see the FAQs on Testing for SARS-CoV-2 webpage.


On this page:


Q: Which product codes are used for transport medium products?

A: This table shows product codes for different types of transport medium products.

Classification Regulation Device Type Product Code Device Classification
21 CFR 866.2300* Culture Media, Non-Selective and Non-Differential JSG I (Exempt)
21 CFR 866.2390** Culture Media, Non-Propagating Transport JSM I (Reserved)
Culture Media, Anaerobic Transport JSL I (Reserved)
Culture Media, Propagating Transport JSN I (Reserved)
21 CFR 866.2900** Device, Specimen Collection LIO I (Reserved)
System, Transport, Aerobic JTW I (Reserved)
Transport Systems, Anaerobic JTX I (Reserved)
21 CFR 866.2950*** Microbial Nucleic Acid Storage and Stabilization Device QBD II

* Generally, transport media consisting of PBS/saline would be regulated by this regulation.
** Generally, transport media consisting of certain types of viral transport media (VTM) would be regulated by these regulations, with the majority under 21 CFR 866.2390.
*** Generally, transport media consisting of certain types of inactivating transport media (ITM) would be regulated by this regulation.

Please note that products in product code QBD are not within the scope of the COVID-19 Transport Media Policy. The remainder of the product codes listed above are within the policy's scope.

Q: Does transport media need to be sterile when used with COVID-19 molecular or antigen assays?

A: As explained in the COVID-19 Transport Media Policy, only VTM devices labeled as sterile should be used in the transport of clinical specimens to avoid introducing microbial contamination in to the specimen. FDA's guidance further explains that the sterility of transport media should be appropriately verified and/or validated prior to distribution, and this should include process sterilization validation and validation that the device remains sterile in its packaging when maintained in accordance with the labeled storage conditions and for the duration of the claimed shelf life.

Q: Do the policies outlined in the COVID-19 Transport Media Policy apply to all types of transport media?

A: No, the policies outlined in the COVID-19 Transport Media Policy only apply to certain transport media devices that can be used to transport certain clinical specimens that are tested by molecular or antigen diagnostic assays for use during availability concerns resulting from the COVID-19 public health emergency. This includes sterile VTM that have been designed and validated consistent with the current version of the CDC's SOP for the Preparation of Viral Transport Media as well as sterile phosphate buffered saline (PBS)/saline transport media.

As discussed in the guidance, these policies are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

This table shows product codes for the different types of transport medium products that are referenced in the policies in the COVID-19 Transport Media Policy.

Classification Regulation Device Type Product Code Device Classification
21 CFR 866.2300* Culture Media, Non-Selective and Non-Differential JSG I (Exempt)
21 CFR 866.2390** Culture Media, Non-Propagating Transport JSM I (Reserved)
Culture Media, Anaerobic Transport JSL I (Reserved)
Culture Media, Propagating Transport JSN I (Reserved)
21 CFR 866.2900** Device, Specimen Collection LIO I (Reserved)
System, Transport, Aerobic JTW I (Reserved)
Transport Systems, Anaerobic JTX I (Reserved)

* Generally, transport media consisting of PBS/saline would be regulated by this regulation.
** Generally, transport media consisting of certain types of viral transport media (VTM) would be regulated by these regulations, with the majority under 21 CFR 866.2390.

Q: Do the policies outlined in the COVID-19 Transport Media Policy apply to commercial manufacturers of viral transport media?

A: Yes, section IV.B of the COVID-19 Transport Media Policy discusses policies specific to commercial manufacturers of certain types of viral transport media that are class I (reserved) and subject to premarket notification requirements under section 510(k) of the FD&C Act. As discussed in the guidance, FDA does not intend to object to the distribution and use of VTM by commercial manufacturers, without a 510(k) and without compliance with the Unique Device Identification (UDI) requirements, where the VTM device is validated, notification of validation is provided to FDA, and certain labeling information is included with the VTM device.

Q: Do the policies outlined in the COVID-19 Transport Media Policy apply to formulations of viral transport media that differ from the CDC's SOP for the Preparation of Viral Transport Media?

A: As stated in the guidance, FDA believes that VTM distributed by commercial manufacturers under this policy should be designed and validated consistent with the Centers for Disease Control and Prevention's (CDC's) Standard Operating Procedure (SOP): Preparation of Viral Transport Media. Generally, transport media may contain different components to serve the function of stabilizing viruses, and FDA understands that some commercial manufacturers may wish to design and validate VTM formulations that may differ from the CDC's SOP for the Preparation of Viral Transport Media. As discussed in section IV.B.4 of the COVID-19 Transport Media Policy, FDA is interested in interacting with commercial manufacturers of alternative formulations of viral transport media that may wish to discuss alternative approaches to validation that are not identified in the policy. Commercial manufacturers that wish to discuss an alternative formulation or validation approach should email [email protected].

Q: Do the policies outlined in the COVID-19 Transport Media Policy apply to inactivating transport media (ITM)?

A: No. The policies outlined in the COVID-19 Transport Media Policy only apply to transport media that are intended to sustain the viability of viruses/other organisms and therefore, do not contain substances such as guanidinium/guanidine or similar chemicals intended to inactivate viruses. The policies in this guidance do not apply to transport media devices intended for viral inactivation, commonly referred to as inactivating transport media (ITM).

Q: Do the policies outlined in the COVID-19 Transport Media Policy apply to commercial manufacturers of saline or phosphate-buffered saline (PBS) that can be used for specimen transport purposes?

A: Yes, section IV.C of the COVID-19 Transport Media Policy outlines policies for commercial manufacturers of sterile saline and PBS transport media. These devices are generally exempt from premarket notification requirements under section 510(k) of the FD&C Act pursuant to 21 CFR 866.2300(b) (Class I Exempt). As discussed in the guidance, FDA does not intend to object to the distribution and use of PBS/saline transport media by commercial manufacturers, without compliance with the Unique Device Identification (UDI) requirements, when the manufacturer gives notification of validation to FDA.

Q: Do I need to manufacture my transport media under a quality system in accordance with 21 CFR Part 820?

A: Yes, transport media are required to comply with all requirements, including 21 CFR Part 820; however, as discussed in the COVID-19 Transport Media Policy, in order to help increase availability of commercially manufactured transport media, FDA does not intend to enforce the Quality System Requirements under 21 CFR Part 820 when commercial manufacturers of VTM or sterile PBS/saline transport media within the scope of the guidance conform to ISO 13485:2016 Medical Devices ̶ Quality Management Systems ̶ Requirements for Regulatory Purposes. The guidance further explains that manufacturers should have documentation demonstrating their compliance with ISO 13485 which should be sent to FDA as part of the manufacturer's notification.

Q: Do I need to notify FDA that I am developing and distributing transport media under the policies outlined in the COVID-19 Transport Media Policy?

A: As discussed in the COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of viral transport media (VTM) devices or PBS/saline transport media devices where the manufacturer gives notification of validation of their transport media devices as outlined in the policy.

The COVID-19 Transport Media Policy explains that following completion of validation, notification that the commercial manufacturer intends to distribute the transport media should be provided to FDA by e-mail to [email protected] that the transport medium has been validated. This notification should include the name of the manufacturer, address, a contact person and e-mail address at which the contact person can be reached, the name(s) under which the product is sold or distributed, names of authorized importers and distributors, a copy of the instructions for use, and a statement and documentation that the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Commercial manufacturers of VTM should also include a statement that the device has been designed and validated consistent with CDC's SOP: Preparation of Viral Transport Media. The FDA will acknowledge receipt of this email via auto-reply.

Additionally, FDA notes in the COVID-19 Transport Media Policy that it would be helpful to the FDA if manufacturers additionally provide information on their expected manufacturing capacity of their transport medium in their notification discussed above. This information will help the Agency and Department monitor the landscape as we work to help ensure adequate testing supplies are available across the country during the COVID-19 public health emergency.

As discussed in section IV.D of the COVID-19 Transport Media Policy, FDA does not expect laboratories to notify FDA if they plan to develop and use a transport media within the same corporate organization and common ownership by the same parent corporation.

Q: Do I need to register my establishment with the FDA and list my device if I am developing and distributing transport media under the policies outlined in the COVID-19 Transport Media Policy? Do I need to comply with any other FDA requirements?

A: As discussed in sections IV.B and IV.C of the COVID-19 Transport Media Policy, FDA does not intend to object to the distribution and use of the applicable products without compliance with certain requirements outlined in the policy. This policy does not apply to compliance with other requirements and manufacturers are responsible for ensuring compliance with those requirements, including Registration and Listing requirements in 21 CFR Part 807, reports of corrections and removals in 21 CFR Part 806, medical device reporting under 21 CFR Part 803, and in vitro diagnostics (IVD) labeling requirements under 21 CFR Parts 801 and 809.

Q: Do the policies outlined in the COVID-19 Transport Media Policy apply to laboratories that develop transport media?

A: Yes, section IV.D of the COVID-19 Transport Media Policy outlines policies applicable to laboratories certified under CLIA that meet the requirements to perform high-complexity testing. As discussed in the guidance, FDA does not intend to object to the development and use of transport media, including VTM, or PBS/saline, for transport of clinical specimens by laboratories certified under CLIA to perform high-complexity testing that meet the requirements to perform high-complexity testing where the transport medium has been validated in-house and where use of the transport medium is limited to laboratories within the same corporate organization and having common ownership by the same parent corporation. FDA does not expect laboratories to notify FDA if they plan to develop and use a transport media within the same corporate organization and common ownership by the same parent corporation.

The COVID-19 Transport Media Policy further recommends that all transport media should be validated prior to use. FDA recommends that laboratories seeking to develop and use their own VTM refer to CDC's SOP: Preparation of Viral Transport Media.

Laboratories seeking to distribute transport media to entities that are not within the same corporate organization and that share common ownership by the same parent corporation should refer to section IV.B or section IV.C of the COVID-19 Transport Media Policy.

Q: What commercial manufacturers are developing and distributing viral transport media (VTM) under the policy outlined in Section IV.B of the COVID-19 Transport Media Policy? (Updated 6/3/22)

A: As described in section IV.B of the FDA's COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of viral transport media (VTM) by commercial manufacturers, without a 510(k) or compliance with the Unique Device Identification (UDI) requirements, where the VTM device is validated, notification of validation is provided to FDA, and certain labeling information is included with the VTM device.

The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute VTM as set forth in Section IV.B of the FDA's COVID-19 Transport Media Policy.

Manufacturer Transport Media Device Name
Biomed Diagnostics Incorporated VTM-C19 Transit Tube
Merit Medical Systems, Inc. Cultura™ Collection and Transport System
Merit Medical Systems, Inc. Cultura™ Transport System
S2 Media Viral Transport Media (VTM)
Vision Biotechnology Company Vision Transport Medium
Wuxi NEST Biotechnology Co., Ltd. Disposable sampler Viral Transport Media manufactured after July 7, 2020
BioTeke Corporation (WUXI) Co. Ltd BioTeke Corporation Sterile Disposable Virus Sampling Swab Kits
Philosys Co., Ltd. Gmate® Universal Transport Medium
General Biologicals Corporation GB Viral Transport Medium (VTM) Kit, Cat. No. 4OO004, 4OO009
Shenzhen Dakewe Bio-engineering Co., LTD BioSci® Disposable Virus Sampling Tube
Zhejiang Sorfa Life Sciences Research Co Ltd Sorfa VTM/Swab Specimen Collection Kit
Citotest Labware Manufacturing Co., Ltd Citoswab® Collection and Transport Kit, P/N 2118-0419
MatTek Corporation MatTek Viral Transport Medium
Azer Scientific Universal Transport Medium
Seasun Biomaterials, Inc. TOP™ Virus Collection Kit
Hangzhou Bioer Technology Co., Ltd Viral Transport Media
Noble Biosciences, Inc. CTM (Clinical Virus Transport Medium)
Welgene, Inc. rmbio VTM
Guangdong Longsee Biomedical Co., Ltd Sample Preservation Solutions (LS-C-P-018)
Huachenyang (Shenzhen) Technology Co., Ltd. iClean® Viral Transport System (VTM-RT), Catalog No. CY-F005-20, CY-F005-20-NGS, CY-F005-20-NGSH, CY-F003-40, CY-F003-40-NGS, CY-F003-40-NGSH
Ruhof Corporation Viral Transport Medium Tube with Swab, Item Code: 345TK‐2
Hunan Vegas Biotech Co., Ltd Virus Transport Kit (Non-inactivated)
Alpha Teknova, Inc. Teknova Viral Transport Medium
LaunchWorks LaunchWorks Viral Transport Media
CPT Medical Ready-To-Use VTM
AccuGene AccuViral Collection Kit
KSL Diagnostics KSL Virus Specimen Collection Kit 4 (Catalogue 52018)
Korea Standard Co., Ltd MedSchenker Smart Transport Medium (STM)
Guangzhou Improve Medical Instruments Co., Ltd IMPROVIRAL Viral Preservative Medium (VPM)
Jiangsu Rongye Technology Co., Ltd. Viral Transport Media (VTM) With Swab
Type: RYCO-VART05B03,  RYCO-VART06B02, RYCO-VART06B03,  RYCO-VART10B03,  RYCO-VART50B15
Oasis Diagnostics Corporation ViroDefender® Virus Transport Medium (VDVTM)
bioBoaVista Viral Transport Media (VTM)
Gemini Bioproducts, LLC Viral Transport Media (600-102)
Nephron Pharmaceuticals Corporation Viral Transport Media
Universal Bioproducts (UBP) Universal COVID-19 Viral Transport Medium
Zhejiang Gongdong Medical Technology Co., Ltd. Disposable Sample Universal Transport Medium
Alpha Teknova, Inc. Teknova Active Viral Transport Medium (ATM)
BrainBits, LLC by Transnetyx BrainBits, LLC Viral Transport Medium
LaunchWorks Viral Transport Media (RT)
HiMedia Laboratories Pvt Ltd HiViral Transport Medium, Product Code: AL167
HiMedia Laboratories Pvt Ltd HiViral Transport Kit, Product Code: MS2760
ARX Sciences ARX VTM Transport System
Wizchem Co., Ltd. COVICHEK Clinical Viral Transport Medium (VTM), Model name: VTM-2M-OSA-T1-NSA-T1
Korea Standard Co., Ltd Medschenker Smart Collection System
Gentueri, Inc. Viral Transport Media (VTM) Kit, Cat. No. 3310-000, 3320-000, 3330-000
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. KaiBiLi™ Extended ViralTrans
Hunan Runmei Gene Technology Co., Ltd. Single Use Samplers manufactured after 15 October, 2020
GDL Korea Co. Ltd Universal Transport Medium (UTM), Cat. No. GDLS1011
Novatek, LLC Disposable Virus Collection Tube and Transportation, Preservation Media
Asan Pharm. Co., Ltd ASAN Transport Medium (O), (I), (II)
BioGenex Laboratories BioGenex Viral Transport Media (BGX-VTM)
Mediatech, Inc. Corning Viral Transport Media, 3mL, Product 25-501-CRS
Mediatech, Inc. Viral Transport Media, 3 mL, Product 25-400-CRS
Zhuhai Lituo Biotechnology Co., Ltd. Disposable Virus Sampling Kit Non-inactivation, Model: A1, A2, A3
Precision (Changzhou) Medical Instruments Co., Ltd Disposable Virus Sampling Tube, Model: PCY-A-F3, PCY-B-F3, PCY-AB-F3, PCY-A, PCY-B
Liofilchem s.r.l. VTM (catalog ref. number 26490U)
AB Medical, Inc. AB Transport Medium (ABTM)
Charm Sciences, Inc. Viral Transport Medium, Product/Order Code: CDC-VTM
Rocky Mountain Biologicals, LLC RMBIO VTM, Cat. No. VTM-BSL-03M
Revital Healthcare (EPZ) Ltd Cady Viral Transport Medium
Saffron Naturele Products Private Limited Advancells Viral Transport Medium
Synergy Innovation Co. Ltd SI-UTM
Changsha Renji Medical Equipment Co., Ltd Viral Transport Medium (VTM) Swab Kits
Precision Medical Devices, Inc. Viral Transport Media (VTM)
Biocomma Limited biocomma Transport and Preservation Medium
Ningbo Dasky Life Science Co., Ltd Disposable Sampling Tube (VSM01) manufactured after March 17, 2021
Lingen Precision Medical Products Co., Ltd Lingen VTM Virus Sampling Tube
Innolyzer Labs, LLC VTM20 Viral Transport Media
Ensol Biosciences Inc. EnTM Collection and Transport System
Jinan Babio Biotechnology Co., Ltd. Babio® Virus Transport Kit (Non-inactivated)
Alpha-Tec Systems, Inc. VTM (Viral Transport Medium) Part number 0003730​
Hardy Diagnostics Viral Transport Medium, Cat. No. R99, R64BX
Virology Testing Products, LLC Disposable Virus Sampling Tube, VTP-011
Thermo Fisher Scientific, Remel Inc. Thermo Scientific™ Remel™ M4RT
Amazing Biotech (Shanghai) Co., Ltd. Multichamber Viral Transport Medium
Hangzhou AllTest Biotech Co., Ltd Viral Transport Medium (Non-Inactivated Type)
Han Chang Medic GTM, Avantik VTM
Han Chang Medic GTM kit: Model HIK+D, HIK+2, HIK+T
3D Medical Supplies, LLC 3DVTM01-1.5ML, 3DVTM01-3.0ML
BigBen Medical Supplies Disposable Virus Sampling Kit, Cat. no. BB-2020, BB-2030
UFC Biotechnology, Inc. Viral Transport Medium, Catalog Number: VTM310
PHC Corp. Phc UTM, Model: PU-019
MedBio, LLC Viral Transport Medium, Catalog Number: V02

Q: What commercial manufacturers are developing and distributing PBS/saline transport media devices under the policy outlined in Section IV.C of the COVID-19 Transport Media Policy? (Updated 3/3/22)

A: As described in section IV.C of the FDA's COVID-19 Transport Media Policy, the FDA does not intend to object to the distribution and use of sterile PBS/saline transport media by commercial manufacturers, without compliance with the Unique Device Identification (UDI) requirements, where the manufacturer gives notification of validation to FDA.

The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute PBS/saline transport media devices as set forth in Section IV.C of the FDA's COVID-19 Transport Media Policy.

Manufacturer Transport Media Device Name
Millenium LifeSciences, Inc. Culture Media Concepts® Sterile Normal Saline, 3 ML V468-3
Millenium LifeSciences, Inc. Culture Media Concepts® Sterile Phosphate Buffered Saline, 3 ML V591-3
Shenzhen Dakewe Bio‐engineering Co., Ltd. Sterile Normal Saline
Shenzhen Dakewe Bio‐engineering Co., Ltd. Sterile Phosphate Buffered Saline
bioBoaVista Saline 0.85%
Gemini Bioproducts, LLC Saline (600-107)
Gemini Bioproducts, LLC Phosphate Buffered Saline (PBS) (600-108)
LaunchWorks LaunchWorks 1x PBS Transport Media
Gentueri, Inc. PBS Response Sample Kit, Cat. No. 3710-000
Greiner Bio-One GmbH VACUETTE® Virus Stabilization Tube, Item Number 456164, 456163
TAAG Genetics S.A VTB, Catalog # TAGC01003, TAGC01010
Lingen Precision Medical Products Co., Ltd Lingen PBS Virus Sampling Tube
Enzo Life Sciences, Inc. AMPICOLLECT™ Saline, NP Swab Kit, Catalog no. ENZ-GEN244
Changsha Renji Medical Equipment Co., Ltd Disposable Virus Specimen Collection Tube
HiMedia Laboratories Pvt. Ltd. Normal Saline, 0.9% normal saline in self standing tube, Product code TL1158
HiMedia Laboratories Pvt. Ltd. Normal Saline, 0.85% normal saline in self standing tube, Product code TL1159
HiMedia Laboratories Pvt. Ltd. Phosphate Buffered Saline, pH 7.2, 1x, Product code TL1031
Ningbo Dasky Life Science Co., Ltd Disposable Sampling Tube (VSM03, VSM05)
Edge Biologicals, Inc. Saline 0.85% 3ml, Part Number: T-0627, T-0627Ga
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