Bio-Whittaker, Inc., A Cambrex Co.
United StatesFDA applicant, unverified
- Devices
- 3
What Bio-Whittaker, Inc., A Cambrex Co. makes
Bio-Whittaker, Inc. manufactures diagnostic tests and cell culture media, including the RUBELISA (RUBESTAT) serological assay for rubella antibody detection and the RHMK II expanded primary rhesus monkey kidney cell culture for laboratory use. The company also produces the TOXOSTAT, a diagnostic test for toxoplasmosis antibody detection.
These products are regulated under FDA’s Class I and Class II device classifications, with relevant submissions recorded in the 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Rubelisa (Rubestat) Ref K950227
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Toxostat Ref K944867
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Whittaker, Inc., A Cambrex Co. have in the registry?
The registry currently lists 3 devices for Bio-Whittaker, Inc., A Cambrex Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Whittaker, Inc., A Cambrex Co.'s devices?
Among its 3 most recently registered devices, Bio-Whittaker, Inc., A Cambrex Co. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bio-Whittaker, Inc., A Cambrex Co.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bio-Whittaker, Inc., A Cambrex Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Whittaker, Inc., A Cambrex Co. in the registry?
The most recently registered devices listed for Bio-Whittaker, Inc., A Cambrex Co. include RUBELISA (RUBESTAT), RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE and TOXOSTAT.