Central Biological Co.
Country not established
- Devices
- 5
What Central Biological Co. makes
Central Biological Co. manufactures diagnostic reagents and laboratory consumables, including the PREGTELL I pregnancy test device, dialysate concentrate for hemodialysis, sterile defibrinated sheep blood for laboratory use, and immunoassay reagents like RHEUMATELL and CRPTELL for detecting rheumatoid factor and C-reactive protein, respectively.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance registry. These products are intended for in vitro diagnostic and therapeutic support applications, and the company operates from the United States.
Catalogue
Pregtell I Ref K792027
Regimes: 510(k) Registry: 510(k)Dialysate Concentrate Ref K812330
Regimes: 510(k) Registry: 510(k)Sterile Defibrinated Sheep Blood Ref K790801
Regimes: 510(k) Registry: 510(k)Rheumatell Ref K790351
Regimes: 510(k) Registry: 510(k)Crptell Ref K792238
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Central Biological Co. have in the registry?
The registry currently lists 5 devices for Central Biological Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Central Biological Co.'s devices?
Among its 5 most recently registered devices, Central Biological Co. has devices listed in FDA 510(k) (5 devices).
What risk classes do Central Biological Co.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Central Biological Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Central Biological Co. in the registry?
The most recently registered devices listed for Central Biological Co. include PREGTELL I, DIALYSATE CONCENTRATE, STERILE DEFIBRINATED SHEEP BLOOD and RHEUMATELL.