Petra Biomedical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Petra Biomedical Products, Inc. makes
Petra Biomedical Products, Inc. manufactures direct fluorescent antibody reagents, including control kits like CONTROLCHEK II™ and CONTROLCHEK™, as well as fluorescent antibody tests such as FLUOR-B MEL A DIRECT FLUORESCENT ANTI and FLUOR-B FRAG. DIRECT FLUORESCENT ANTI. These products are designed for microbiological and diagnostic testing applications.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. The products are registered in the United States, where the manufacturer is based.
Catalogue
Controlchek Ii(Tm) Ref K873034
Regimes: 510(k) Registry: 510(k)Fluor-B Mel A Direct Fluorescent Anti Ref K833613
Regimes: 510(k) Registry: 510(k)Controlchek(Tm) Ref K871445
Regimes: 510(k) Registry: 510(k)Fluor-B. Frag. Direct Fluorescent Anti Ref K833612
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Petra Biomedical Products, Inc. have in the registry?
The registry currently lists 4 devices for Petra Biomedical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Petra Biomedical Products, Inc.'s devices?
Among its 4 most recently registered devices, Petra Biomedical Products, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Petra Biomedical Products, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Petra Biomedical Products, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Petra Biomedical Products, Inc. in the registry?
The most recently registered devices listed for Petra Biomedical Products, Inc. include CONTROLCHEK II(TM), FLUOR-B MEL A DIRECT FLUORESCENT ANTI, CONTROLCHEK(TM) and FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI.