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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 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PY with MANNITOL 7mL | AS-848 | EUDAMEDFDA UDI | Class A | Active |
| PY with XYLAN 7mL | AS-859 | EUDAMEDFDA UDI | Class A | Active |
| PYG 500mL | AS-8225 | EUDAMEDFDA UDI | Class A | Active |
| CCMB-TAL BROTH 5mL | AS-8216 | EUDAMEDFDA UDI | Class A | Active |
| PY with INULIN 7mL | AS-845 | EUDAMEDFDA UDI | Class A | Active |
| Pras Lkv | AS-112 | EUDAMEDFDA UDI | Class A | Active |
| OTEB 500mL | AS-6035 | EUDAMEDFDA UDI | Class A | Active |
| PY with INOSITOL 7mL | AS-844 | EUDAMEDFDA UDI | Class A | Active |
| Columbia Agar W/Colistin, Naladixic | K841139 | FDA 510(k) | Class I | Active |
| Trypticase Soy Agar W/5% Sheep Blood | K841130 | FDA 510(k) | Class I | Active |
| Anaerobic Brucella Blood Agar | K791562 | FDA 510(k) | Class I | Active |
| Lombard-Dowell Deoxyrilbonucleric Acid | K790627 | FDA 510(k) | Class I | Active |
| Anaerobic Brucella Laked Blood Agar | K791563 | FDA 510(k) | Class I | Active |
| Lombard-Dowell Broth Medium | K790619 | FDA 510(k) | Class I | Active |
| Mueller Hinton Agar W/Blood & Cofactor | K841138 | FDA 510(k) | Class II | Active |
| Lombard-Dowell Necmycin Egg Yolk Agar | K790628 | FDA 510(k) | Class I | Active |
| Strips | K840029 | FDA 510(k) | Class I | Active |
| Lombard-Dowell Starch Agar | K790618 | FDA 510(k) | Class I | Active |
| Campylobacter Selective Medium | K791578 | FDA 510(k) | Class I | Active |
| Hektoen Enteric Agar | K841129 | FDA 510(k) | Class I | Active |
| Thayer Martin Medium | K841133 | FDA 510(k) | Class I | Active |
| Carbohydrate Fermentation Media | K790617 | FDA 510(k) | Class I | Active |
| Ana Trans Tube & Swabs Sterile Pack | K834357 | FDA 510(k) | Class I | Active |
| Microbial Differentiation | K840031 | FDA 510(k) | Class I | Active |
| Mueller Hinton Agar W/Wo Blood | K841137 | FDA 510(k) | Class II | Active |
| Macconkey Agar | K841141 | FDA 510(k) | Class I | Active |
| Sabouraud Dextrose Agar W/Chloramphe | K841136 | FDA 510(k) | Class I | Active |
| Enriched Thioglycollate Medium | K790616 | FDA 510(k) | Class I | Active |
| Cycloserine-Cefoxitin Fructose Agar | K841218 | FDA 510(k) | Class I | Active |
| Anaerobic Brucella Blood Agar | K791579 | FDA 510(k) | Class I | Active |
| Cdc Anaerobe Blood W/Kanamyan/Vancom. | K781602 | FDA 510(k) | Class I | Active |
| Phenylethyl Alcohol Blood Agar | K841140 | FDA 510(k) | Class I | Active |
| Bile Differential Disk | K844380 | FDA 510(k) | Class I | Active |
| Discs | K840028 | FDA 510(k) | Class I | Active |
| Campylobacter Thioglycollate Med | K841303 | FDA 510(k) | Class I | Active |
| Kanamycin 1000 Mcg Differential Disk | K844383 | FDA 510(k) | Class I | Active |
| Vancomycin 5mcg Differential Disk | K844382 | FDA 510(k) | Class I | Active |
| Lombard-Dowell Glucose Agar | K790626 | FDA 510(k) | Class I | Active |
| Lombard-Dowell Broth Medium W/Lactate | K790624 | FDA 510(k) | Class I | Active |
| Mycosel Agar W/Chloramphenicol & | K841135 | FDA 510(k) | Class I | Active |
| Chopped Meat Glucose Medium | K790621 | FDA 510(k) | Class I | Active |
| Colistin 10 Mcg. Differential Disk | K844381 | FDA 510(k) | Class I | Active |
| Cdc Anaerobe Blood Agar | K781604 | FDA 510(k) | Class I | Active |
| Lombard Dowell Broth Mediumw/Th Reonine | K790620 | FDA 510(k) | Class I | Active |
| Chocolate Agar W/Cofactor | K841144 | FDA 510(k) | Class I | Active |
| Lombard-Dowell Milk Agar | K790623 | FDA 510(k) | Class I | Active |
| Bacteroides Bile Esculin Gar | K841222 | FDA 510(k) | Class I | Active |
| Plate, Ld Presumpto | K781856 | FDA 510(k) | Class I | Active |
| Peptone-Yeast Extract Broth | K790625 | FDA 510(k) | Class I | Active |
| Mannitol Salt Agar | K841134 | FDA 510(k) | Class I | Active |
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