Otisville Biopharm, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Otisville Biopharm, Inc. makes
Otisville Biopharm, Inc. manufactures microbiological culture media and diagnostic reagents, including selective and differential agar plates for identifying specific bacteria such as *Haemophilus ducreyi*, *Legionella* species, and *Brucella*. Products include BIOTIS™ Inhibitory Mold Agar, BIOTIS™ Sabouraud Dextrose Agar with Hexachlorophene (SABHI), and BIOTIS™ Mueller Hinton Agar with oxacillin for antimicrobial susceptibility testing. Additional formulations support starch hydrolysis assays and blood agar-based media with antimicrobial supplements for bacterial isolation.
The company’s portfolio consists of Class I medical devices, which are generally low-risk products regulated under the FDA’s 510(k) pathway. These products are listed in the FDA’s 510(k) database and comply with U.S. regulatory requirements for microbiological culture media. Otisville Biopharm, Inc. is headquartered in the United States.
Catalogue
Biotis (Tm) Haemophilus Ducreyi Ref K874176
Regimes: 510(k) Registry: 510(k)Biotis (Tm) Inhibitory Mold Agar (Double Pour) Ref K874172
Regimes: 510(k) Registry: 510(k)Biotis (Tm) Sabhi (Double Pour) Ref K874179
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Biotis (Tm) Starch Hydrolysis With Bcp Ref K874174
Regimes: 510(k) Registry: 510(k)Biotis (Tm) Bcye Selective Ref K874178
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Biotis (Tm) Bcye Ref K874177
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Otisville Biopharm, Inc. have in the registry?
The registry currently lists 8 devices for Otisville Biopharm, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Otisville Biopharm, Inc.'s devices?
Among its 8 most recently registered devices, Otisville Biopharm, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Otisville Biopharm, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Otisville Biopharm, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Otisville Biopharm, Inc. in the registry?
The most recently registered devices listed for Otisville Biopharm, Inc. include BIOTIS (TM) HAEMOPHILUS DUCREYI, BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR), BIOTIS (TM) SABHI (DOUBLE POUR) and BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC.