The Upjohn Co.
Country not established
- Devices
- 8
What The Upjohn Co. makes
The company produces diagnostic in-vitro assay kits for hormone measurement, including radioimmunoassay (RIA) systems for testosterone and progesterone, as well as bioluminescent assay kits for creatine kinase (CK) levels. It also manufactures sterile susceptibility powders for antimicrobial testing, such as Zephazone, Trobicin, Linocin, and Cleocin (clindamycin).
These products are regulated under FDA classifications, including Class I and Class II devices, with some requiring 510(k) clearance and others a Premarket Approval (PMA). The company’s diagnostic and susceptibility testing kits are listed in the FDA’s regulatory databases.
Catalogue
Testosterone Radioimmunoassay Kit 125I Ref K780792
Regimes: 510(k) Registry: 510(k)Ria Kit, Progesterone Ref K782009
Regimes: 510(k) Registry: 510(k)Zefazone Susceptibility Powder Ref K900455
Regimes: 510(k) Registry: 510(k)Cat-A-Kit Ref K760920
Regimes: 510(k) Registry: 510(k)Ck-Total/Ck-B (Nac) Biolumin. Assay Kit Ref K810853
Regimes: 510(k) Registry: 510(k)- Regimes: PMA 510(k) Registry: PMA
Lincocin Susceptibility Pwd Ref N61034
Regimes: PMA Registry: PMA- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does The Upjohn Co. have in the registry?
The registry currently lists 8 devices for The Upjohn Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Upjohn Co.'s devices?
Among its 8 most recently registered devices, The Upjohn Co. has devices listed in FDA 510(k) (5 devices) and FDA PMA (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do The Upjohn Co.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for The Upjohn Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Upjohn Co. in the registry?
The most recently registered devices listed for The Upjohn Co. include TESTOSTERONE RADIOIMMUNOASSAY KIT 125I, RIA KIT, PROGESTERONE, ZEFAZONE SUSCEPTIBILITY POWDER and CAT-A-KIT.