Fermco Biochemics, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Fermco Biochemics, Inc. makes
Fermco Biochemics, Inc. manufactures diagnostic reagent kits and systems for laboratory testing, including glucose measurement via glucose oxidase and glucose dehydrogenase-peroxidase (GOD-PAP) methods, chloride reagents, blood urea nitrogen (BUN) rate reagents, creatinine reagents, carbon dioxide (CO₂) reagents, and triglycerides reagent systems.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These reagents and test kits are listed in the FDA’s 510(k) database, reflecting their authorised status for in vitro diagnostic use in the United States.
Catalogue
Germco Test R Glucose Test Kit Ref K810567
Regimes: 510(k) Registry: 510(k)Rermco Test Chloride Reagent Ref K823106
Regimes: 510(k) Registry: 510(k)Glucose God-Pap Trinder Method Test Kit Ref K791066
Regimes: 510(k) Registry: 510(k)Glucose Oxidase Reagent Ref K781945
Regimes: 510(k) Registry: 510(k)Fermcotest R Bun Rate Reagent Test Kit Ref K791018
Regimes: 510(k) Registry: 510(k)Fermcotest Creatinine Test Reagent Ref K822118
Regimes: 510(k) Registry: 510(k)Fermcotest CO2 Reagnet Ref K822117
Regimes: 510(k) Registry: 510(k)Triglycerides Reagent System Ref K843832
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fermco Biochemics, Inc. have in the registry?
The registry currently lists 8 devices for Fermco Biochemics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fermco Biochemics, Inc.'s devices?
Among its 8 most recently registered devices, Fermco Biochemics, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Fermco Biochemics, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Fermco Biochemics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fermco Biochemics, Inc. in the registry?
The most recently registered devices listed for Fermco Biochemics, Inc. include GERMCO TEST R GLUCOSE TEST KIT, RERMCO TEST CHLORIDE REAGENT, GLUCOSE GOD-PAP TRINDER METHOD TEST KIT and GLUCOSE OXIDASE REAGENT.