Genchem Inc
United StatesFDA applicant, unverified
- Devices
- 39
What Genchem Inc makes
GenChem Inc manufactures laboratory reagents and calibrators for clinical chemistry, including electrolyte buffers, CO₂ acid reagents, azo dye-based calcium reagents, and calibrators for blood urea nitrogen (BUN) and creatinine assays. Their portfolio also covers glucose oxidase-based glucose reagents and ion-selective electrode (ISE) reference electrolytes for analytical testing.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered with the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 39 devicesCompany details
- DUNS number
- 193856866
- [email protected]
- Phone
- +1(714)529-7125
Frequently asked questions
How many devices does GENCHEM INC have in the registry?
The registry currently lists 39 devices for GENCHEM INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list GENCHEM INC's devices?
Among its 39 most recently registered devices, GENCHEM INC has devices listed in FDA 510(k) (8 devices) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GENCHEM INC's devices fall under?
Among its 39 most recently registered devices, the classes recorded for GENCHEM INC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from GENCHEM INC in the registry?
The most recently registered devices listed for GENCHEM INC include GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1 GEN-CAL 1, GENCHEM™ Total Protein Reagent GEN-TP, GENCHEM™ Creatinine Test Reagent GEN-CREA R2(Acid) and GENCHEM™Calcium, Azo Dye Reagent GEN-CA3.