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    FDA Registration Active 🇺🇸 United States

    American Laboratory Products Company

    Reg #: 1222302 · FEI: 1000121039 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    93
    Establishment Types
    3
    Classifications
    38

    Registration Details

    Registration Name
    American Laboratory Products Company
    Registration Number
    1222302
    FEI Number
    1000121039
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    26 Keewaydin Drive, Unit G
    City
    Salem
    State
    NH
    ZIP
    03079
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123364

    Owner / Operator

    Firm Name
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Operator Number
    9000664
    Address
    26 KEEWAYDIN DR., BLDG- G
    City
    Salem
    State
    NH
    Postal Code
    03079
    Country
    US
    Correspondent
    James Richard

    Products

    Device Name Product Code
    System, Test, Vitamin D MRG
    Visual, Pregnancy Hcg, Prescription Use JHI
    Radioimmunoassay, Calcitonin JKR
    Radioimmunoassay, Acth CKG
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Radioimmunoassay, Pregnenolone JNG
    Radioimmunoassay, Luteinizing Hormone CEP
    General Purpose Reagent PPM
    Anti-Dna Antibody, Antigen And Control LSW
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Radioimmunoassay, Progesterone JLS
    Radioimmunoassay, Parathyroid Hormone CEW
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Calprotectin, Fecal NXO
    Radioimmunoassay, Androstenedione CIZ
    Radioimmunoassay, Total Estrogens, Nonpregnancy JMD
    Radioimmunoassay, Estradiol CHP
    Radioimmunoassay, Human Growth Hormone CFL
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Antigen, Agglutinating, Echinococcus Spp. GPF
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Assay, Erythropoietin GGT
    System, Test, Anticardiolipin Immunological MID
    Radioimmunoassay, Glucagon JME
    Ige, Antigen, Antiserum, Control DGC
    Radioimmunoassay, Estriol CGI
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Lactoferrin, Antigen, Antiserum, Control DEG
    Radioimmunoassay, Estrone CGF
    Radioimmunoassay, Immunoreactive Insulin CFP
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin JNN
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Radioimmunoassay, Total Triiodothyronine CDP
    Radioimmunoassay, Prolactin (Lactogen) CFT

    Proprietary Names

    25OH Vitamin D Total ELISA Total 25-OH Vitamin D ELISA Human Chorionic Gonadotropin ELISA (hCG ELISA) Human Chroionic Gonad. EIA Calcitonin ELISA ACTH EIA Adrenocorticotropic Hormone ELISA (ACTH ELISA) Easy Stool Extraction Device Easy 2 Stool Extraction Device Unfilled Easy 2 Stool Extraction Devices Pregnenolone EIA Pregnenolone ELISA Luteinizing Hormone EIA LH (Luteinizing Hormone) (Urine) ELISA Luteinizing Hormone ELISA (LH ELISA) Sample Extraction Buffer Anti-ds-DNA-G ELISA Free Testosterone ELISA Progesterone EIA Progesterone ELISA Intact PTH ELISA (1-84) Anti-Beta 2 Glycoprotein Screen ELISA ALPCO Calprotectin Turbidimetric Assay Androstenedione ELISA Androstenedione EIA Total Estrogens ELISA Estradiol EIA Ultrasensitive Estradiol ELISA Estradiol ELISA Estradiol Ultrasensitive EIA Serum Testosterone ELISA Total Testosterone ELISA Human Growth Hormone ELISA (HGH ELISA) Human Growth Hormone EIA Human Growth Hormone ELISA (HGH) ELISA Follicle Stimulating Hormone ELISA (FSH ELISA) Follicle Stimulating Hormone EIA Echinococcus granulosus (IgG) ELISA Echinococcus Granulosus IgG ELISA Anti-Tissue Transglutaminase-A ELISA Anti Tissue Transglutaminase-G ELISA (Anti-tTg-G ELISA) Anti-tTg-A ELISA 17-?-OH Progesterone ELISA 17-alpha Hydroxy Progesterone ELISA Total Thyroxine ELISA (Total T4 ELISA) Erythropoietin ELISA (EPO ELISA) Anti-Cardiolipin-A ELISA Glucagon RIA Glucagon ELISA Total IgE ELISA IgE EIA Free Estriol (E3) EIA Free Estriol (E3) ELISA Free Estriol EIA Estriol EIA Free Estriol ELISA Estriol ELISA C-peptide ELISA STELLUX Intact Proinsulin Chemiluminescence ELISA STELLUX C-peptide Chemiluminescence ELISA C-peptide ELISA, Jumbo Pack STELLUX Proinsulin (Intact) Chemiluminescence ELISA Proinsulin (Intact) Chemiluminescence ELISA Intact Proinsulin Chemiluminescence ELISA C-peptide Chemiluminescence ELISA Lab Pack STELLUX Proinsulin (Total) Chemiluminescence ELISA STELLUX C-peptide Chemiluminescence ELISA Lab Pack Lactoferrin CLIA Kit Lactoferrin CLIA Re-Calibrator and Control Set Estrone EIA Estrone ELISA STELLUX Chemi Human Insulin ELISA STELLUX Chemi Human Insulin ELISA, Jumbo Pack Ultrasensitive Insulin ELISA Insulin ELISA Insulin ELISA, Jumbo Pack Ultrasensitive Insulin ELISA, Jumbo Pack Dehydroepiandrosterone Sulfate ELISA (DHEA-S ELISA) DHEA Elisa DHEA-S EIA Dehydroepiandrosterone ELISA (DHEA ELISA) Pancreatic Elastase Chemiluminescence ELISA Pancreatic Elastase CLIA Kit Pancreatic Elastase CLIA Re-Calibrator and Control Set ALPCO Easy Stool Extraction Device ALPCO Calprotectin Chemiluminescence ELISA STELLUX® Chemi Calprotectin ELISA ANA-8Pro ELISA ENA-6Pro ELISA T3 Total ELISA, EIA-4569 Prolactin EIA Prolactin ELISA 17-alpha Hydroxy Progesterone ELISA (Saliva)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198