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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 5 of 5
DeviceModel / ReferenceRegistriesClassStatus
PRAS Anaerobic Transport Medium (ATM) AS-911
EUDAMEDFDA UDI
Class AActive
PY with ESCULIN 7mL AS-833
EUDAMEDFDA UDI
Class AActive
PY with STARCH 7mL AS-829
EUDAMEDFDA UDI
Class AActive
PRAS THIOGLYCOLATE BROTH (5mL) AS-805
EUDAMEDFDA UDI
Class AActive
PRAS YCFAC (4 plates /pkg) AS-675
EUDAMEDFDA UDI
Class AActive
BHI BROTH 250mL AS-8722
EUDAMEDFDA UDI
Class AActive
PRAS FSA (4 plates /pkg) AS-6427
EUDAMEDFDA UDI
Class AActive
BRU DEEP CLSI 17mL AS-809
EUDAMEDFDA UDI
Class AActive

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