Anaerobe Systems
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000040030 FEI 2916932
Anaerobe Systems is a medical device manufacturer based in the United States, with 217 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class A; FDA Class I and II) as of 14 Nov 2026.
- Devices
- 217
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 153
- EUDAMED 132
- FDA 510(k) 52
- Device classes
- EU Class A 132
- FDA Class I 83
- FDA Class II 2
- Top EMDN categories
- Reagents 132
- Sites and related companies
- Casus Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000040030
- FDA FEI 2916932
- DUNS 021192653
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Casus Europe B.V.NL
What Anaerobe Systems makes
Anaerobe Systems manufactures in vitro diagnostics (IVDs) for culturing and identifying anaerobic microorganisms, including nutrient broths, selective/differential agars, and microbial reagents. Products include PRAS Liquid Dental Transport Medium for sample preservation, PRAS Peptone Yeast Extract Broth variants for microbial growth, and PRAS agar media like Bacteroides vulgatus Selective Agar. The company also supplies manual buffered diluents, catalase and indole production reagents, and an AS-500 anaerobic chamber for controlled microbial environments.
The portfolio comprises Class A, Class I, and Class II devices, regulated under FDA 510(k) and UDI requirements in the US and listed in the EU’s eudamed database. These products are designed for clinical and laboratory use, adhering to regulatory standards for in vitro diagnostics.
Catalogue
Search and filter all 217 devicesShowing 1-50 of 217
Company details
- EUDAMED SRN
- US-MF-000040030
- FDA FEI number
- 2916932
- DUNS number
- 021192653
- EUDAMED status
- Active
- EUDAMED registered name
- Anaerobe Systems
- Registered address
- 15906, Concord Circle, 95037, Morgan Hill, United States
- Website
- www.anaerobesystems.com
- linkedin.com/company/biolog-inc.
- facebook.com/biologcompany
- Phone
- +1 (408) 782 7557
- PRRC contact
- Mary Cox
From the company website
Refer to the Quality Control section of the Instructions for Use (IFUs) for each media product. Each insert provides a list of organisms used for quality control testing at Anaerobe Systems, including the ATCC number for the appropriate strain(s). Not all organisms are required for user quality control testing. Please refer to the Centers for Medicare & Medicaid Services (CMS) requirements for Clinical Laboratory Improvement Amendments (CLIA) or your lab’s implemented Individual Quality Control Plan (IQCP) requirements for more information.
Frequently asked questions
How many devices does Anaerobe Systems have in the registry?
The registry currently lists 217 devices for Anaerobe Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Anaerobe Systems's devices?
Among its 50 most recently registered devices, Anaerobe Systems has devices listed in EUDAMED (12 devices), FDA 510(k) (5 devices) and FDA GUDID (45 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Anaerobe Systems's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Anaerobe Systems's devices are Class I and IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Anaerobe Systems in the registry?
The most recently registered devices listed for Anaerobe Systems include PRAS Cycloserine Cefoxitin Fructose Agar w/ Horse Blood & Taurocholate AS-2436, PRAS FAA-HB, LEVINE EOSIN METHYLENE BLUE AGAR and XYLOSE LYSINE DESOXYCHOLATE AGAR.