BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANAEROBE SYSTEMS

    Reg #: 2916932 · FEI: 2916932 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    147
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    ANAEROBE SYSTEMS
    Registration Number
    2916932
    FEI Number
    2916932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15906 CONCORD CIRCLE
    City
    MORGAN HILL
    State
    CA
    ZIP
    95037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K834357

    Owner / Operator

    Firm Name
    Biolog Inc
    Operator Number
    10094615
    Address
    15906 Concord Circle
    City
    Morgan Hill
    State
    CA
    Postal Code
    95037
    Country
    US
    Correspondent
    Steve M Cox

    Products

    Device Name Product Code
    Anaerobic Box Glove JTM
    Culture Media, Non-Selective And Differential JSH
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    Culture Media, Selective And Non-Differential JSJ
    Culture Media, Selective And Differential JSI
    Culture Media, Non-Selective And Non-Differential JSG
    Culture Media, Enriched KZI
    Culture Media, General Nutrient Broth JSC
    Culture Media, Anaerobic Transport JSL

    Proprietary Names

    AS-580 Anaerobic Chamber AS-150 Anaerobic Chamber AS-500 Anaerobic Chamber CM 250mL BOTTLE BRU SINGLES PY with GELATIN CMC 250mL CMC 500mL CM 500mL BOTTLE BRU 150 mm CMC TUBES EYA SINGLE TSBA 4PK CMG 250mL BRU QUADS CMG 500mL CM TUBES CMG TUBES OHO-C W/LEAD ACETATE INDOLE REAGENT ESCULIN REAGENT CATALASE REAGENT FSA AGAR PEA SINGLES CAMPY CFAT P. GING 4PK LMRS AGAR 4PK TSBV AGAR 4PK CAMPY-WOL LMRS BROTH 9ML BIFIDO PEA QUADS PYG with BILE CBA 4PK CAMPY-THIO TUBES CCFA-HT SINGLE TSA-NAM 4PK BBE SINGLES BRU PEA LKV BBE mono CVE AGAR 4PK BRU PEA mono BBE/LKV biplate LKV QUAD BVSA BBE/LKV SINGLE BBE/LKV QUADS BBE QUADS CCMB-TAL BROTH BRU mono BBE/PEA biplate BSM QUAD ETSA-NV CCFA SINGLE LKV SINGLES BRU mono BBE/LKV biplate MSAT 4PK CCFA-L BRU LKV PEA mono BHI BROTH 250mL BHI YMEA 2 PACK TSA-TL 2 PACK BRUCELLA AGAR DEEP BHI BROTH 500mL BRUCELLA AGAR DEEP CLSI 19mL BHI BROTH BRUCELLA AGAR DEEP CLSI 17mL RCA ETSA 4PK CHOC SINGLE COLUMBIA AGAR (CA) OTEB BROTH 250mL YCFAC AGAR 4 PACK BHIY-HT MTGE AGAR 4 PACK CHOCOLATE AGAR 4 PACK CDC AGAR 4PK OTEB TUBE YCFAC+B AGAR 4 PACK YCFAC BROTH 500mL MTGE BROTH TUBES MTGE BROTH 250mL MTGE BROTH 500mL YCFAC BROTH 250mL OTEB TUBE 500mL YCFAC BROTH TUBES PY with MANNITOL PY with LACTOSE PYG FA/GLC 10ml PY with GLUCOSE 250mL THIO 7mL PY with STARCH PY with FRUCTOSE PY with GLYCEROL DILUTION BLANKS 9mL PY with ADONITOL BRU BROTH PY with ERYTHRITOL PY with PYRUVIC ACID PY with GLUCOSE 500mL RCB 7ML INDOLE/NITRATE DILUTION BLANK 500mL PY with GALACTOSE PY with ARGININE PY with MELEZITOSE PEPTONE YEAST EXTRACT 250 mL DILUTION BLANKS 10 mL PY with SUCROSE TUBES PY with CELLOBIOSE PYG with FORMATE/FUMARATE PY with SALICIN TUBES PY with INOSITOL PY with INULIN PY with RAFFINOSE RCB 500mL PY with SORBITOL PY with AMYGDALIN PY with ESCULIN PY with LACTATE PY with XYLOSE TUBES PY with GLUCOSE TUBES PY with MELIBIOSE DILUTION BLANK 250mL PY with RHAMNOSE PY with MALTOSE TUBES DILUTION BLANKS 7mL PY with MANNOSE PY with XYLAN PEPTONE YEAST EXTRACT THIO 5mL PY with TREHALOSE TUBES PY with RIBOSE PY with DULCITOL PY with ARABINOSE PYG with TWEEN PY with DL THREONINE DILUTION BLANKS 3mL PEPTONE YEAST EXTRACT 500 mL RCB 250mL DILUTION BLANKS 18mL TISSUE TRANSPORT SURGERY PK ANAEROBIC TISSUE TRANSPORT8mL ANAEROBIC TRANSPORT MEDIUM DENTAL TRANSPORT 5mL ANAEROBIC TRANSPORT SURGERY PK TISSUE TRANSPORT SURGERY PK BOX LIQUID DENTAL TRANSPORT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device