Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Anaerobe 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
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
DeviceModel / ReferenceRegistriesClassStatus
Cdc Anaerobe Blood Agar W/Phenethylalch. K781603
FDA 510(k)
Class IActive
Chopped Meat Agar K790622
FDA 510(k)
Class IActive
Shopped Meat Carbohydrate K841219
FDA 510(k)
Class IActive
Reagents K840030
FDA 510(k)
Class IActive
Eile-Esculin Azide Agar K841132
FDA 510(k)
Class IActive
PRAS BRU BROTH (4mL) AS-105
EUDAMEDFDA UDI
Class AActive
PY with MELIBIOSE 7mL AS-851
EUDAMEDFDA UDI
Class AActive
OTEB 250mL AS-6032
EUDAMEDFDA UDI
Class AActive
PY with TREHALOSE 7mL AS-831
EUDAMEDFDA UDI
Class AActive
CMC 100mL AS-8231
EUDAMED
Class AActive
YCFAC 250mL AS-6802
EUDAMEDFDA UDI
Class AActive
PRAS BRU PEA LKV BBE (4 plates /pkg) AS-444
EUDAMEDFDA UDI
Class AActive
PRAS CCFA-L (1 plate) AS-2133
EUDAMEDFDA UDI
Class AActive
RCB 100mL AS-6063
EUDAMED
Class AActive
PY with XYLOSE 7mL AS-832
EUDAMEDFDA UDI
Class AActive
PRAS YCFAC+B (4 plates /pkg) AS-677
EUDAMEDFDA UDI
Class AActive
PRAS BRUCELLA (150mm) AS-614
EUDAMEDFDA UDI
Class AActive
BRU BROTH 500 mL AS-1055
EUDAMED
Class AActive
PRAS OHO-C (4 plates /pkg) AS-6430
EUDAMEDFDA UDI
Class AActive
PYG w/FORMATE+FUMARATE 10mL AS-858
EUDAMEDFDA UDI
Class AActive
CM 100mL AS-8111
EUDAMED
Class AActive
PRAS BRU, PEA, BBE/LKV (3 plates /pkg) AS-323
EUDAMEDFDA UDI
Class AActive
PRAS YMEA (2 plates /pkg) AS-229
EUDAMEDFDA UDI
Class AActive
PY with RIBOSE 7mL AS-854
EUDAMEDFDA UDI
Class AActive
PYG with POLYSORBATE 10mL AS-825
EUDAMEDFDA UDI
Class AActive
PYG 250mL AS-8222
EUDAMEDFDA UDI
Class AActive
CMC 500mL AS-8235
EUDAMEDFDA UDI
Class AActive
PRAS CA (4 plates /pkg) AS-895
EUDAMEDFDA UDI
Class AActive
BRU DEEP CLSI 19mL AS-808
EUDAMEDFDA UDI
Class AActive
PRAS BRU LKV PEA (3 plates /pkg) AS-303
EUDAMEDFDA UDI
Class AActive
PRAS PEA (4 plates /pkg) AS-143
EUDAMEDFDA UDI
Class AActive
CM 250mL AS-8112
EUDAMEDFDA UDI
Class AActive
PY with CELLOBIOSE 7mL AS-837
EUDAMEDFDA UDI
Class AActive
LMRS BROTH 250mL AS-6092
EUDAMED
Class AActive
PRAS BSM (4 plates /pkg) AS-223
EUDAMEDFDA UDI
Class AActive
PY with SORBITOL 7mL AS-855
EUDAMEDFDA UDI
Class AActive
PRAS CHOPPED MEAT (7mL) AS-811
EUDAMEDFDA UDI
Class AActive
LMRS BROTH 9mL AS-609
EUDAMEDFDA UDI
Class AActive
PYG with BILE 7mL AS-857
EUDAMEDFDA UDI
Class AActive
PRAS LKV (4 plates /pkg) AS-142
EUDAMEDFDA UDI
Class AActive
PY with ARABINOSE 7mL AS-824
EUDAMEDFDA UDI
Class AActive
PRAS RCA (4 plates /pkg) AS-6061
EUDAMEDFDA UDI
Class AActive
Pras Bru AS-111
EUDAMEDFDA UDI
Class AActive
PY with SUCROSE 7mL AS-830
EUDAMEDFDA UDI
Class AActive
PRAS TSBV (4 plates /pkg) AS-648
EUDAMEDFDA UDI
Class AActive
PY with MALTOSE 7mL AS-847
EUDAMEDFDA UDI
Class AActive
PY with SALICIN 7mL AS-828
EUDAMEDFDA UDI
Class AActive
YCFAC BROTH 7mL AS-680
EUDAMEDFDA UDI
Class AActive
PRAS BBE/LKV (4 plates /pkg) AS-242
EUDAMEDFDA UDI
Class AActive
PRAS BRU (4 plates/pkg) AS-141
EUDAMEDFDA UDI
Class AActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.