Biowhittaker Molecular Applications, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Biowhittaker Molecular Applications, Inc. makes
The company produces diagnostic test kits for detecting antibodies, including RHEUMELISA II kits for SCL-70, JO-1, and histone antibodies, as well as rapid STAT tests for IgM and mumps. It also supplies specimen transport media and software solutions for laboratory equipment, such as firmware for the BioWhittaker 2001 microplate reader and WHITSOFT cartridge software for plate readers.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company is based in the United States.
Catalogue
Rheumelisa Ii Scl-70 Antibody Test Kit Ref K930130
Regimes: 510(k) Registry: 510(k)Specimen Transport Medium Ref K935618
Regimes: 510(k) Registry: 510(k)Rf Stat Igm Test Kit Ref K920753
Regimes: 510(k) Registry: 510(k)Mumps Stat Ref K925209
Regimes: 510(k) Registry: 510(k)Biowhittaker 2001 Microplate Reader Firmware Ref K942245
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Whitsoft Ref K942361
Regimes: 510(k) Registry: 510(k)Rheumelisa Ii Jo-1 Antibody Test Kit Ref K930757
Regimes: 510(k) Registry: 510(k)Varicelisa, Modification Ref K943843
Regimes: 510(k) Registry: 510(k)Rheumelisa Ii Histone Antibody Test Kit Ref K932679
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biowhittaker Molecular Applications, Inc. have in the registry?
The registry currently lists 10 devices for Biowhittaker Molecular Applications, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biowhittaker Molecular Applications, Inc.'s devices?
Among its 10 most recently registered devices, Biowhittaker Molecular Applications, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Biowhittaker Molecular Applications, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Biowhittaker Molecular Applications, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biowhittaker Molecular Applications, Inc. in the registry?
The most recently registered devices listed for Biowhittaker Molecular Applications, Inc. include RHEUMELISA II SCL-70 ANTIBODY TEST KIT, SPECIMEN TRANSPORT MEDIUM, RF STAT IGM TEST KIT and MUMPS STAT.