Molecular Biosystems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Molecular Biosystems, Inc. makes
Molecular Biosystems, Inc. produces diagnostic test kits for bacterial and viral pathogens, including the SNAP CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT for Campylobacter identification, the SNAP ROTAVIRUS DIAGNOSTIC KIT for rotavirus detection, and THE EXTRACTOR for sample preparation. It also manufactures ALBUNEX ECHOCARDIOGRAPHY CONTRAST MICROSPHERES, a contrast agent for echocardiographic imaging.
The company’s diagnostic kits and contrast agent are regulated under FDA pathways, with some products classified as Class I and others as Class III. These devices are authorised via 510(k) clearances and Premarket Approval Applications (PMA). The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
The Extractor(Tm) Ref K873932
Regimes: 510(k) Registry: 510(k)Snap Campylobactor Diagnostic Kit Ref K873670
Regimes: 510(k) Registry: 510(k)Snap(R) Rotavirus Diagnostic Kit Ref K873565
Regimes: 510(k) Registry: 510(k)- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Molecular Biosystems, Inc. have in the registry?
The registry currently lists 5 devices for Molecular Biosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Molecular Biosystems, Inc.'s devices?
Among its 5 most recently registered devices, Molecular Biosystems, Inc. has devices listed in FDA 510(k) (4 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Molecular Biosystems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Molecular Biosystems, Inc.'s devices are Class I and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Molecular Biosystems, Inc. in the registry?
The most recently registered devices listed for Molecular Biosystems, Inc. include SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT, THE EXTRACTOR(TM), SNAP CAMPYLOBACTOR DIAGNOSTIC KIT and SNAP(R) ROTAVIRUS DIAGNOSTIC KIT.