BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GERMAINE LABORATORIES, INC.

    Reg #: 1649661 · FEI: 3001451797 · Expires 2026
    View on FDA
    Products
    78
    Proprietary Names
    25
    Establishment Types
    4
    Classifications
    78

    Registration Details

    Registration Name
    GERMAINE LABORATORIES, INC.
    Registration Number
    1649661
    FEI Number
    3001451797
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11030 Wye Drive
    City
    SAN ANTONIO
    State
    TX
    ZIP
    78217
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061559

    Owner / Operator

    Firm Name
    GERMAINE LABORATORIES, INC.
    Operator Number
    9031523
    Address
    11030 Wye Drive
    City
    San Antonio
    State
    TX
    Postal Code
    78217
    Country
    US
    Correspondent
    Craig A Waldrip

    Products

    Device Name Product Code
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test, Urine Leukocyte LJX
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Blood, Occult, Colorimetric, In Urine JIO
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Refractometer For Clinical Use JRE
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Antigens, All Groups, Streptococcus Spp. GTY
    System, Test, Human Chorionic Gonadotropin DHA
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Reagent, Occult Blood KHE
    Antiserum, Positive And Negative Febrile Antigen Control Serum GSN
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Amphetamine DKZ
    Gas Chromatography, Methamphetamine LAF
    Devices, Breath Trapping, Alcohol DJZ
    System, Test, Infectious Mononucleosis KTN
    Glucose Oxidase, Glucose CGA
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Ldl & Vldl Precipitation, Hdl LBR
    System, Test, Blood Glucose, Over The Counter NBW
    Colorimetric Method, Triglycerides JGY
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Opiates, Over The Counter NGL
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Automated Urinalysis System KQO
    Helicobacter Pylori LYR
    Antigens, Nontreponemal, All GMQ
    Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. GNC
    Antisera, Fluorescent, Brucella Spp. GSM
    Antiserum, Francisella Tularensis GSK
    Test, Benzodiazepine, Over The Counter NFV
    Test, Methamphetamine, Over The Counter NGG
    Test, Propoxyphene, Over The Counter QBF
    Test, Methadone, Over The Counter PTG
    Test, Barbiturate, Over The Counter PTH
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Cannabinoid, Over The Counter NFW
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Propoxyphene JXN
    Radioimmunoassay, Luteinizing Hormone CEP
    Antigens, Febrile (Weil-Felix), All Groups GSZ
    Antisera, Fluorescent, All Globulins, Proteus Spp. GSY
    Test, Morphine, Over The Counter NGI
    Enzymatic Method, Creatinine JFY
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Recorder, Paper Chart DSF
    Antigens, All Groups, Salmonella Spp. GRL
    Investigational Use Only - Clinical Chemistry PDA
    Test System, Nicotine, Cotinine, Metabolites MRS
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    System, Test, C-Reactive Protein DCN
    Control, Hemoglobin GGM
    System, Hemoglobin, Automated GKR
    Diazo Colorimetry, Bilirubin CIG
    Test, Nitrite, Urinary, Non-Quantitative, Over The Counter NGJ
    Drug Mixture Control Materials DIF
    System, Test, Rheumatoid Factor DHR
    Urinalysis Controls (Assayed And Unassayed) JJW
    Antisera, All Groups, Salmonella Spp. GRM
    Antigens (Febrile), Agglutination, Brucella Spp. GSO
    Antigens, Slide And Tube, Francisella Tularensis GSL

    Proprietary Names

    AimStrip Xylazine AimScreen Fentanyl AimScreen Xylazine AimStrip Fentanyl FisherBrand 40B Urine Reagent Strips FisherBrand 2P Urine Reagent Strips FisherBrand 5P Urine Reagent Strips StrepAim Strep A Test Pregcolor Premium FisherBrand Urine Analyzer AimStep H. Pylori SafeCup III 13-F AimStrip Mosie Baby Ovulation Test AimStep AccuHome Compliance Gold Mosie Baby Pregnancy Test SafeCup III 12-M AimStrip MACRE FisherBrand 2CE Urine Reagent Strips FisherBrand Thermal Printer Paper AimStrip Thermal Printer Paper Cotinine Positive Control Cotinine Negative Control

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Remanufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility