2019 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| IH-COM V5.2 Automated Blood Grouping and Antibody Test Systems |
IH-Com V5.2 is data management and result interpretation software used in immunohematology testing to analyze reaction images for blood samples that are tested on the IH-1000, IH-500 and IH-Reader 24 with IH-System reagents or the TANGO infinity® with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data. IH-Com V5.2 may be used with:
Recommendation: Operators of IH-Com V5.2 have to be trained by authorized personnel and have to be familiar with the content of this IH-Com V5.2 User Manual U.S. The IH-Com V5.2 User Manual U.S. is designed to serve as a reference manual for operations and safety instructions. |
BK190424/0 | Bio-Rad Medical Diagnostics GmbH 6565 185th Avenue NE Redmond, Washington 98052 |
12/20/2019 |
| ZipThaw™ 202 Blood and Plasma Warming Devices |
The FMS ZipThaw™ 202 is a thawing device intended for use in blood banks and laboratories for the following applications
|
BK190401/0 | Fremon Scientific, Inc. QSite 31 Haavoda Street Binyamina 3054431 Israel |
12/18/2019 |
| MTS Buffered Gel Card Automated Blood Grouping and Antibody Test Systems |
For the detection of antibodies to red blood cells For the detection of antigens to red blood cells For in vitro diagnostic use only For use with the ID-Micro Typing System™ |
BK190400/0 | Micro Typing Systems Inc. 1295 Southwest 29th Avenue Pompeo Beach, FL 33069 |
12/17/2019 |
| ORTHO VISION Max Analyzer Automated Blood Grouping and Antibody Test Systems |
ORTHO VISION Max Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing ID-MTS gel card technology. ORTHO VISION Max Analyzer automates test processing function including liquid pipetting, reagent handling, incubation, centrifugation, reacting grading and interpretation and data management requirements using cards and digital image processing. ORTHO VISION Max Analyzer can be used as a standalone instrument or interfaced to the customer's Laboratory Information System (LIS). | BK190399/0 | Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202 Raritan, NJ 08869-0606 |
12/17/2019 |
| TANGO Infinity Automated Blood Grouping and Antibody Test Systems |
The TANGO infinity automated blood grouping and antibody test system is an automated instrument intended for the in vitro serological analysis of human blood specimens. In the USA, TANGO infinity is ''Rx only'' and operates with TANGO infinity Software Version 1.6. It generates results from individual images that must be verified by visual inspection by a qualified person called a validator. In rare cases, where the software is unable to decide, manual editing may be necessary. TANGO infinity utilizes Erytype S agglutination methodology for ABO (forward and reverse blood grouping), Rh(D), Rh Phenotype and Kell blood grouping. TANGO infinity utilizes Solidscreen II solidphase methodology for weak D and partial D testing, antibody screening and identification of red cell alloantibodies, crossmatch, auto control and direct antiglobulin testing. The TANGO infinity uses reagents and microwell strips approved for the TANGO infinity. Operators of TANGO infinity must be trained by authorized personnel and must be familiar with the content of this TANGO infinity User Manual. This TANGO infinity User Manual is designed to serve as a reference manual for operations and troubleshooting, to assist writing institutional SOPs and to assist training. |
BK190388/0 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories 6565 185th Avenue NE Redmond, WA 98052 |
12/13/2019 |
| WADiana Compact Automated Blood Grouping and Antibody Test Systems |
The WADiana® Compact Analyzer is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel® 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana® Compact Analyzer automates test processing functions and data management requirements using DG Gel® 8 cards and digital image processing. | BK190321/0 | Diagnostic Grifols, S. A. Passeig Fluvial 24 Parets Del Valles Barcelona 08150 Spain |
12/10/2019 |
| DG Reader Automated Blood Grouping and Antibody Test Systems |
The DG Reader is a device designed to read, interpret, and generate reports of the results of processed DG Gel® 8 cards. The instrument also identifies DG Gel® 8 cards by reading their barcodes. As a stand-alone instrument or interfaced to the customer’s Laboratory Information System (LIS), the DG Reader automates data management requirements using DG Gel® 8 cards and digital image processing. |
BK190320/0 | Diagnostic Grifols, S. A. Passeig Fluvial 24 Parets Del Valles Barcelona 08150 Spain |
12/10/2019 |
| Erytra Automated Blood Grouping and Antibody Test Systems |
The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel® 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), the Erytra® automates test processing functions and data management requirements using DG Gel® 8 cards and digital image processing. | BK190318/0 | Diagnostic Grifols, S. A. Passeig Fluvial 24 Parets Del Valles Barcelona 08150 Spain |
12/10/2019 |
| Terumo Operational Medical Equipment Software (TOMEs), Version 7.1 Blood Establishment Computer Software and Accessories |
TOMEs (Terumo Operational Medical Equipment software) is software that enables defined workflow management of connected equipment to enforce user created algorithms that help facilitate donation management and the manufacture of blood components. | BK190333/0 | Terumo BCT, Inc 10810 West Collins Avenue Lakewood, CO 80215 |
12/03/2019 |
| ALBAcheck® BGS Monoclonal Control Quality Control Kits for Blood Banking Reagents |
ALBAcheck® BGS Monoclonal Control is intended for use as a negative control in conjunction with ALBAclone® Blood Grouping reagents (where referenced in the reagent IFU). | BK190389/0 | Alba Bioscience Limited 5 James Hamilton Way Penicuik, EH26 0BF Scotland, United Kingdom |
11/26/2019 |
| RD2 System Peripheral blood processing device for wound management |
The RD2 System is intended to be used at point‐of‐care for the safe and rapid preparation of Whole Blood Clot (WBC) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC gel produced by the RD2 System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically‐debrided wounds. | BK190349/0 | RedDress Ltd 1735 Market Street, 23rd Floor Philadelphia, PA 19104 |
11/08/2019 |
| Arthrex Double Syringe (ACP) kit Platelet And Plasma Separator For Bone Graft Handling |
The Arthrex Double Syringe (ACP) Kit is indicated for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK190406/0 | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 |
11/06/2019 |
| Fidia PRP Kit Platelet And Plasma Separator For Bone Graft Handling |
The Fidia PRP Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK180296/0 | Fidia Farmaceutici S.p.A. Fidia Pharma USA 100 Campus Drive, Suite 105 Florham Park, NJ 07932 |
11/05/2019 |
| DG Reader Net Automated Blood Grouping and Antibody Test Systems |
The DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing. |
BK190379/0 | Diagnostic Grifols, S. A. Passeig Fluvial, 24 Parets Del Valles Barcelona 08150 Spain |
10/11/2019 |
| Arthrex Angel® System Platelet and Plasma Separator for Bone Graft Handling |
The Arthrex Angel System Kits are to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The platelet poor plasma and platelet rich plasma are mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. | BK190383/0 | Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108 |
09/18/2019 |
| BloodRelay 1.0.0 Blood Establishment Computer Software and Accessories |
BloodRelay is intended to integrate with site-validated third-party systems and assist authorized and trained blood bank personnel to:
|
BK190361/0 | Alliance Technologies, LLC 1552 West Griswold Road Phoenix, AZ 85021 |
09/17/2019 |
| ADAMII CD34 System Automated Differential Cell Counter |
The ADAMII™ CD34 System includes the ADAMII™-CD34 Kit which is designed for use with the ADAMII™ Instrument, a benchtop image-based fluorescence cell counter. The ADAMII™ CD34 System provides enumeration of viable CD34 cells/µL, viable CD45+ cells/µL, and calculates viable % CD34+ of viable CD45+ for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA and haematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin. The ADAMII™ CD34 System is intended for use in clinical laboratories and for in vitro diagnostic use only. It is not intended for use in point-of-care settings. |
BK180283/0 | NanoEntek, Inc. MEDIcept, Inc. 200 Homer Drive Ashland, MA 01721 |
08/09/2019 |
| PK7400 TP HA Controls PK7400 TP HA Reagent Test, Syphilis, Treponema (FOR DONOR TESTING) |
PK7400 TP HA REAGENT is intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. The PK7400 TP HA REAGENT is not intended for diagnostic use. PK7400 TP HA CONTROLS are intended for use with the PK7400 TP HA REAGENT for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. |
BK180301/0 | Newmarket Biomedical Ltd Unit 1 Lanwades Business Park Kentford, Suffolk United Kingdom CB8 7PN |
08/01/2019 |
| Aurora Plasmapheresis System, Software Version 2.1 Automated blood cell separator |
The Aurora Plasmapheresis System is an automated plasmapheresis system designed to collect plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma | BK190368/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 |
07/26/2019 |
| Plasmalink Bottle with Locking Luer Adapter Empty Containers for the Collection and Processing of Blood and Blood Components |
The Plasma Pooling Bottle is used for the collection, storage, and shipment of plasma prior to fractionation. | BK190362/0 | Fresenius Kabi AG Three Corporate Drive Lake Zurich, IL 60047 |
07/19/2019 |
| Timestrip Blood Temp 10(BT10) Blood Bank Supplies |
The Timestrip® Blood Temp 10 (BT10) blood bag indicator is a temperature-sensitive indicator that can be used by blood banks and transfusion services to maintain quality control in blood storage and transportation. | BK190363/0 | Timestrip UK Ltd. Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090 |
07/19/2019 |
| MTS™ Buffered Gel Card Automated Blood Grouping and Antibody Test Systems |
For the detection of antibodies to red blood cells For in vitro diagnostic use only For use with the ID-Micro Typing System™ Contains: 6 tests per card |
BK190339/0 | Micro Typing Systems Inc. Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202 North Raritan, New Jersey 08869-0606 |
07/08/2019 |
| ORTHO VISION® Analyzer Automated Blood Grouping and Antibody Test System |
ORTHO VISION® Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing ID-MTS™ gel card technology. ORTHO VISION® Analyzer automates test processing functions including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation and data management requirements using cards and digital image processing. ORTHO VISION® Analyzer can be used as a standalone instrument or interfaced to the customer's Laboratory Information System (LIS). | BK190338/0 | Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202, Raritan, NJ 08869 |
07/08/2019 |
| Galileo NEO Automated Blood Grouping and Antibody Test Systems |
The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can then be subjected to confirmation using a licensed method. The NEO is intended for use only with the reagents described in Attachment 1 for Galileo Neo Operator Manual. | BK190337/0 | Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 |
06/19/2019 |
| VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) Fibrin Sealant Preparation Device |
The VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) is intended to be used with the VISTASEAL™ Dual Applicator for the simultaneous topical application of the two biological components ofVISTASEAL™ Fibrin Sealant (Human) onto the surface. | BK190324/0 | ETHICON Inc. Route 22 West, P.O. Box 151, Somerville, NJ 08876 |
06/05/2019 |
| ALYX Component Collection System Automated Blood Cell Separators |
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components. Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection System has been cleared for: • Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced − Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted • Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced − Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted • Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as: − Fresh Frozen Plasma • Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy. − Source Plasma − Plasma Frozen Within 24 Hours After Phlebotomy (PF24) • Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at - 18°C or colder within 24 hours after phlebotomy. • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. − Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) • Can be stored at room temperature for up to 24 hours after phlebotomy. • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. • Collection of Plasma as: − Fresh Frozen Plasma, • Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy. − Source Plasma − Plasma Frozen Within 24 Hours After Phlebotomy (PF24) • Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at - 18°C or colder within 24 hours after phlebotomy. • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. − Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) • Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy. • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. |
BK190351/0 | Fresenius Kabi USA LLC. Three Corporate Drive Lake Zurich, IL 60047 |
06/04/2019 |
| Trima Accel Automated Blood Collection System Automated Blood Cell Separators |
The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients. Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:
Or the following products alone or in combination:
Storage of RBCs Collected on the Trima Accel system
Storage of Platelets Collected on the Trima Accel system
Storage of Plasma Collected on the Trima Accel system
Rx only. |
BK190332/0 | Terumo BCT, Inc 10811 W. Collins Avenue, Lakewood, CO 80215-4415 |
05/22/2019 |
| NBM-200 Pulse Oximeter and Hemoglobin Monitor Hemoglobin for donor testing |
The NBM-200 is a portable Hemoglobin and oximetry monitor. It non-invasively spot checks and displays Hemoglobin (Hb), estimated Hematocrit (Hct) values, functional saturation of arterial oxygen hemoglobin (SpO2), and pulse rate (PR). These parameters can be displayed periodically for patient monitoring. The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in non-critical clinical and non-clinical settings, e.g., non-critical settings in hospitals, hospital-type facilities, blood donation settings, mobile environments, clinics, physician offices and ambulatory surgery centers. In this context, non-critical means patient examination settings where continuous monitoring is unnecessary. Non-critical environments exclude, for example, intensive care units. |
BK190322/0 | OrSense Ltd Covington & Burling LLP One City Center, 850 Tenth Street, NW Washington, DC 20001-4956 |
05/09/2019 |
| TANGO infinity Automated Blood Grouping and Antibody Test Systems |
The TANGO infinity automated blood grouping and antibody test system is an automated instrument intended for the in vitro serological analysis of human blood specimens. In the USA, TANGO infinity is ''Rx only'' and operates with TANGO infinity Software Version 1.5. It generates results from individual images that must be verified by visual inspection by a qualified person called a validator. In rare cases, where the software is unable to decide, manual editing may be necessary. TANGO infinity utilizes Erytype S agglutination methodology for ABO (forward and reverse blood grouping), Rh(D), Rh Phenotype and Kell blood grouping. TANGO infinity utilizes Solidscreen II solidphase methodology for weak D and partial D testing, antibody screening and identification of red cell alloantibodies, crossmatch, auto control and direct antiglobulin testing. The TANGO infinity uses reagents and microwell strips approved for the TANGO infinity. Operators of TANGO infinity must be trained by authorized personnel and must be familiar with the content of this TANGO infinity User Manual. This TANGO infinity User Manual is designed to serve as a reference manual for operations and troubleshooting, to assist writing institutional SOPs and to assist training. |
BK190312/0 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories, Inc. 6565 185th Avenue, NE Redmond, WA 98052 |
04/24/2019 |
| VISTASEAL Airless Spray Accessory Fibrin Sealant Preparation Device |
The VistaSeal Airless Spray Accessory device is intended to be used with VistaSeal Fibrin Sealant (Human) for the simultaneous topical application of the two biological components of VistaSeal Fibrin Sealant (Human) onto the surface. | BK180287/0 | ETHICON Inc. Route 22 West, Somerville, NJ 08876 |
04/10/2019 |
| XCELL PRP™ Platelet Concentrating System 60ml Platelet And Plasma Separator For Bone Graft Handling |
The XCELL PRP™ System is intended to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to the application to a bony defect for improving handling characteristics. | BK180252/0 | APEX Biologix 5650 South Green St, Murray, UT 84123 |
04/05/2019 |
| IH-500 Analyzer Automated Blood Grouping and Antibody Test System |
The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, provides reaction grading / interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control and direct antiglobulin testing. | BK180274/0 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories, Inc. 6565 185th Avenue, NE Redmond, WA 98052 |
03/21/2019 |
| IH-Com V5.0 Automated Blood Grouping and Antibody Test System |
IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for blood samples that are tested on the IH-1000, IH-500 and IH-Reader 24 with IH-System reagents or the TANGO infinity® with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with:
|
BK180275/0 | Bio-Rad Medical Diagnostics GmbH Bio-Rad Laboratories, Inc. 6565 185th Avenue, NE Redmond, WA 98052 |
03/21/2019 |
| Arthrex Thrombinator System Platelet And Plasma Separator For Bone Graft Handling |
The Thrombinator System for use with Arthrex PRP systems (Arthrex Angel concentrated Platelet Rich Plasma cPRP System or Arthrex Double Syringe (ACP) System) is designed for the preparation of autologous serum from anticoagulated or non-anticoagulated peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics. | BK180299/0 | Arthrex, Inc. 1370 Creekside Boulevard, Naples, FL 34108 |
03/07/2019 |
| ALBAcyte® lgG Sensitized Red Blood Cells II Quality Control Kits for Blood Banking Reagents |
These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT). | BK180286/0 | Alba Bioscience Limited James Hamilton Way, Penicuik, Midlothian EH26 OBF United Kingdom |
02/05/2019 |
| MacoPress Smart Smarter and DMS Plus Blood Bank Supplies |
The MacoPress Smart Smarter and DMS Plus consist of two parts: the MacoPress Smart Smarter device and the DMS Plus management software. The MacoPress Smart Smarter is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS Plus software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed. |
BK180306/0 | MacoProductions S.A.S. MacoPharma USA 3075 Breckinridge Boulevard, Suite 405 Duluth, GA 30096 |
01/24/2019 |
| Vista Information System Blood Establishment Computer Software and Accessories |
The Vista System is intended for use in facilities that are automating the process associated with managing donor information, including information about blood collection and manufacture of blood components, with the following functions:
|
BK180258/0 | Terumo BCT, Inc 10811 W. Collins Ave., Lakewood, CO 80215 |
01/18/2019 |
| DG Gel Essential Control Quality Control Kits for Blood Banking Reagents |
DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures for: (i) the determination of the ABO, Rh and K antigens; (ii) the determination of the appropriate ABO blood group antibodies; and (iii) the detection of unexpected antibodies. For use with DG Gel 8 technique. For in vitro diagnostic use. |
BK180280/0 | Medion Grifols Diagnostics AG Grifols SA Avda. de la generalitat, 152 Sant cugat del valles 08174 Spain |
01/17/2019 |