Bio-Rad Laboratories, Inc., Clinical Systems Divis
United StatesFDA applicant, unverified
- Devices
- 6
What Bio-Rad Laboratories, Inc., Clinical Systems Divis makes
Bio-Rad Laboratories, Inc., Clinical Systems Division makes hemoglobin testing systems and related kits, including the VARIANT II TURBO HBA1C KIT-2.0 and VARIANT II HEMOGLOBIN A1C PROGRAM, which are used for measuring hemoglobin A1c levels in clinical laboratories.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Variant(Tm) Ii Turbo HBA1C Kit - 2.0 Ref K130990
Regimes: 510(k) Registry: 510(k)Modification To Variant Ii: Hemoglobin A1C Program, Beta-Thalassemia Short Program And Total Ghb Program Ref K063643
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Rad Laboratories, Inc., Clinical Systems Divis have in the registry?
The registry currently lists 6 devices for Bio-Rad Laboratories, Inc., Clinical Systems Divis. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Rad Laboratories, Inc., Clinical Systems Divis's devices?
Among its 6 most recently registered devices, Bio-Rad Laboratories, Inc., Clinical Systems Divis has devices listed in FDA 510(k) (6 devices).
What risk classes do Bio-Rad Laboratories, Inc., Clinical Systems Divis's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bio-Rad Laboratories, Inc., Clinical Systems Divis's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Rad Laboratories, Inc., Clinical Systems Divis in the registry?
The most recently registered devices listed for Bio-Rad Laboratories, Inc., Clinical Systems Divis include VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH, VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,, VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM and VARIANT(TM) II TURBO HBA1C KIT - 2.0.