BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRINCETON BIOMEDITECH CORP.

    Reg #: 2246703 · FEI: 2246703 · Expires 2026
    View on FDA
    Products
    43
    Proprietary Names
    121
    Establishment Types
    2
    Classifications
    43

    Registration Details

    Registration Name
    PRINCETON BIOMEDITECH CORP.
    Registration Number
    2246703
    FEI Number
    2246703
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4242 U.S. Hwy. 1
    City
    Monmouth Jct
    State
    NJ
    ZIP
    08852
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100341

    Owner / Operator

    Firm Name
    PRINCETON BIOMEDITECH CORP.
    Operator Number
    2246703
    Address
    4242 U.S. HIGHWAY 1, --
    City
    Monmouth Junction
    State
    NJ
    Postal Code
    08852
    Country
    US

    Products

    Device Name Product Code
    Semen Analysis Device POV
    System, Test, Infectious Mononucleosis KTN
    Enzyme Immunoassay, Opiates DJG
    Thin Layer Chromatography, Methamphetamine DJC
    Kit, Test, Multiple, Drugs Of Abuse, Over The Counter MVO
    System, Test, Human Chorionic Gonadotropin DHA
    Antisera, Fluorescent, All Types, Staphylococcus Spp. GTN
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Test System, For Drugs Of Abuse MGX
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    Antigens, All Groups, Streptococcus Spp. GTY
    Enzyme Immunoassay, Amphetamine DKZ
    Reagents, Test, Tetrahydrocannabinol DKE
    High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs LFI
    High Pressure Liquid Chromatography, Methamphetamine LAG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Nicotine And Nicotine Metabolites MKU
    Visual, Pregnancy Hcg, Prescription Use JHI
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Radioimmunoassay, Barbiturate DKN
    Reagent, Occult Blood KHE
    Enzyme Immunoassay, Cannabinoids LDJ
    Gas Chromatography, Methamphetamine LAF
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Immunoassay Method, Troponin Subunit MMI
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Liquid Chromatography, Amphetamine DNI
    U.V. Spectrometry, Tricyclic Antidepressant Drugs LFH
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Myoglobin, Antigen, Antiserum, Control DDR
    Chromatographic Separation, Cpk Isoenzymes JHT
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Myoglobin, Fitc, Antigen, Antiserum, Control DEA
    Radioimmunoassay, Luteinizing Hormone CEP
    Helicobacter Pylori LYR
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer LOJ
    Test, Natriuretic Peptide NBC
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    SpermCheck Fertility BioSign Mono Status Mono Status DS Oxy Accusign MET BioStrip P Status hCG Strip BIOSIGN STREP A--DIRECT STR Accusign TCA DBdau DOA7 (THC/OPI/COC/MET//BAR/BZO/AMP) Accusign BUP BioSign Rubella BioStrepA Status First Strep A BioSign Strep A AccuSign RC DOA 10 (MET/OPI/COC/THC Status First DOA 10 StatusFirst DOA10/StatusFirst DOA5 Status Strep A Strip StatusStrep A Plus Accusign MTD STATUS HCG BIOSIGN HCG Status Nicotine AccuSign Nicotine Status hCG S/U BioSign hCG S/U BioSign Flu A+B StatusFlu A&B LifeSign Home Drug Test (THC/COC) Accusign BAR Status DS DOA 9 AccuSign DOA 10 Status DS DOA 10 AccuSign DOA 8 AccuSign DOA 9 Status Stik THC/OPI/COC/AMP or MET/ Status iFOBT BioSign iFOBTest Accusign BZO ACCUSIGN DOA 10 Panel STATUS STIK COC LIFESIGN HOME DRUG TEST COC Status DS (COC/THC/OPI) AccuSign DOA3 (COC/THC/OPI) Status First Sperm Check Vasectomy AccuSign BAR Status DS BAR Status DS THC/OPI/COC/AMP/BZO/BAR/T AccuSign DOA8 (THC/OPI/COC/AMP/BZO/ Status DS MET AccuSign MET Status COVID-19/Flu control set (5 Pos/5 Neg) BioSign Mono Pos/Neg control Status Mono Pos/Neg controls (2 x 1 mL) BioSign Flu control set (5 Pos/5 Neg) Status Flu control set (5 Pos/5 Neg) Status iFOBT control set Pos/Neg (2 x 1 mL) PBM Qualitative Cardiac Marker Control Set (2 x 1mL) Status Drugs of Abuse Controls (2 x 5mL) Status hCG urine Pos/Neg controls (2 x 2.5 mL) BioSign hCG S/U Pos/Neg controls (2 x 3 mL) Status COVID-19 Antigen Controls (1 pos/1 neg); Bulk Status H. pylori Pos/Neg controls (2 x 1 mL) Cardiac Status Troponin I LifeSign MI Troponin I Status DS BZO AccuSign BZO Status AccuStrep A Status DS AMP or MET AccuSign DOA 4/AMP or MET ACCUSIGN OPI StatusFirst D-Dimer Status DS (THC/OPI/COC/MET or AMP/P AccuSign DOA5 (THC/OPI/COC/MET or A Status Strep A Flip BioSign Strep A Flip Status Flu A&B Status DS TCA AccuSign TCA LifeSign Plus StatusFirst TnI Quantitative LifeSign One LifeSign 1 Status COVID-19/Flu A&B STATUS CK-MB/MYO StatusFirst hCG Serum/Urine LIFESIGN DX READER LifeSign MI CK-MB/Myoglobin/Trop I Cardiac STATus CK-MB/Myoglob/Trop I Clarity Status DS AMP AccuSign AMP Status DS THC AccuSign THC AccuSign COC StatusDS COC AccuSign PCP Status DS PCP AccuSign DOA 2 COC/THC Status DS COC/THC LifeSign MI Myoglobin/Troponin I Status DS BAR/BZO AccuSign DOA2 BAR/BZO LIFESIGN HOME DRUG TEST THC STATUS STIK THC DOA 8 OvuSign LH/ Conception Plus AccuSign MTD Status DS MTD Status First H.pylori LifeSign MI Status DS MOP AccuSign MOP BioSign MOP DOA 4 LifeSign Home Drug Test (THC/OPI/CO StatusFirst CHF NT-proBNP Ovusign Ovulation Predictor Status COVID-19/Flu Test Status COVID-19/Flu A&B Test

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only