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Sign in to claim this brandAnaerobe Systems
United States·US-MF-000040030
Last updated September 17, 2026
About
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.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 15906 , Concord Circle, Morgan Hill, United States
- Website
- www.anaerobesystems.com
- linkedin.com/company/biolog-inc.
- facebook.com/biologcompany
- [email protected]
- Phone
- +1 (408) 782 7557
- PRRC Contact
- Mary Cox
- EUDAMED SRN
- US-MF-000040030
- FDA FEI Number
- 2916932
- DUNS Number
- —
Catalogue (208)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cdc Anaerobe Blood Agar W/Phenethylalch. | K781603 | FDA 510(k) | Class I | Active |
| Chopped Meat Agar | K790622 | FDA 510(k) | Class I | Active |
| Shopped Meat Carbohydrate | K841219 | FDA 510(k) | Class I | Active |
| Reagents | K840030 | FDA 510(k) | Class I | Active |
| Eile-Esculin Azide Agar | K841132 | FDA 510(k) | Class I | Active |
| PRAS BRU BROTH (4mL) | AS-105 | EUDAMEDFDA UDI | Class A | Active |
| PY with MELIBIOSE 7mL | AS-851 | EUDAMEDFDA UDI | Class A | Active |
| OTEB 250mL | AS-6032 | EUDAMEDFDA UDI | Class A | Active |
| PY with TREHALOSE 7mL | AS-831 | EUDAMEDFDA UDI | Class A | Active |
| CMC 100mL | AS-8231 | EUDAMED | Class A | Active |
| YCFAC 250mL | AS-6802 | EUDAMEDFDA UDI | Class A | Active |
| PRAS BRU PEA LKV BBE (4 plates /pkg) | AS-444 | EUDAMEDFDA UDI | Class A | Active |
| PRAS CCFA-L (1 plate) | AS-2133 | EUDAMEDFDA UDI | Class A | Active |
| RCB 100mL | AS-6063 | EUDAMED | Class A | Active |
| PY with XYLOSE 7mL | AS-832 | EUDAMEDFDA UDI | Class A | Active |
| PRAS YCFAC+B (4 plates /pkg) | AS-677 | EUDAMEDFDA UDI | Class A | Active |
| PRAS BRUCELLA (150mm) | AS-614 | EUDAMEDFDA UDI | Class A | Active |
| BRU BROTH 500 mL | AS-1055 | EUDAMED | Class A | Active |
| PRAS OHO-C (4 plates /pkg) | AS-6430 | EUDAMEDFDA UDI | Class A | Active |
| PYG w/FORMATE+FUMARATE 10mL | AS-858 | EUDAMEDFDA UDI | Class A | Active |
| CM 100mL | AS-8111 | EUDAMED | Class A | Active |
| PRAS BRU, PEA, BBE/LKV (3 plates /pkg) | AS-323 | EUDAMEDFDA UDI | Class A | Active |
| PRAS YMEA (2 plates /pkg) | AS-229 | EUDAMEDFDA UDI | Class A | Active |
| PY with RIBOSE 7mL | AS-854 | EUDAMEDFDA UDI | Class A | Active |
| PYG with POLYSORBATE 10mL | AS-825 | EUDAMEDFDA UDI | Class A | Active |
| PYG 250mL | AS-8222 | EUDAMEDFDA UDI | Class A | Active |
| CMC 500mL | AS-8235 | EUDAMEDFDA UDI | Class A | Active |
| PRAS CA (4 plates /pkg) | AS-895 | EUDAMEDFDA UDI | Class A | Active |
| BRU DEEP CLSI 19mL | AS-808 | EUDAMEDFDA UDI | Class A | Active |
| PRAS BRU LKV PEA (3 plates /pkg) | AS-303 | EUDAMEDFDA UDI | Class A | Active |
| PRAS PEA (4 plates /pkg) | AS-143 | EUDAMEDFDA UDI | Class A | Active |
| CM 250mL | AS-8112 | EUDAMEDFDA UDI | Class A | Active |
| PY with CELLOBIOSE 7mL | AS-837 | EUDAMEDFDA UDI | Class A | Active |
| LMRS BROTH 250mL | AS-6092 | EUDAMED | Class A | Active |
| PRAS BSM (4 plates /pkg) | AS-223 | EUDAMEDFDA UDI | Class A | Active |
| PY with SORBITOL 7mL | AS-855 | EUDAMEDFDA UDI | Class A | Active |
| PRAS CHOPPED MEAT (7mL) | AS-811 | EUDAMEDFDA UDI | Class A | Active |
| LMRS BROTH 9mL | AS-609 | EUDAMEDFDA UDI | Class A | Active |
| PYG with BILE 7mL | AS-857 | EUDAMEDFDA UDI | Class A | Active |
| PRAS LKV (4 plates /pkg) | AS-142 | EUDAMEDFDA UDI | Class A | Active |
| PY with ARABINOSE 7mL | AS-824 | EUDAMEDFDA UDI | Class A | Active |
| PRAS RCA (4 plates /pkg) | AS-6061 | EUDAMEDFDA UDI | Class A | Active |
| Pras Bru | AS-111 | EUDAMEDFDA UDI | Class A | Active |
| PY with SUCROSE 7mL | AS-830 | EUDAMEDFDA UDI | Class A | Active |
| PRAS TSBV (4 plates /pkg) | AS-648 | EUDAMEDFDA UDI | Class A | Active |
| PY with MALTOSE 7mL | AS-847 | EUDAMEDFDA UDI | Class A | Active |
| PY with SALICIN 7mL | AS-828 | EUDAMEDFDA UDI | Class A | Active |
| YCFAC BROTH 7mL | AS-680 | EUDAMEDFDA UDI | Class A | Active |
| PRAS BBE/LKV (4 plates /pkg) | AS-242 | EUDAMEDFDA UDI | Class A | Active |
| PRAS BRU (4 plates/pkg) | AS-141 | EUDAMEDFDA UDI | Class A | Active |
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