BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TOSOH AIA, INC.

    Reg #: 9612316 · FEI: 3002808328 · Expires 2026
    View on FDA
    Products
    58
    Proprietary Names
    324
    Establishment Types
    2
    Classifications
    58

    Registration Details

    Registration Name
    TOSOH AIA, INC.
    Registration Number
    9612316
    FEI Number
    3002808328
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2, IWASEKOSHI-MACHI
    City
    TOYAMA
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K023891
    PMA Number
    P910065

    Owner / Operator

    Firm Name
    TOSOH BIOSCIENCE
    Operator Number
    8031673
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    Postal Code
    43123
    Country
    US
    Correspondent
    Isabelle Lang-Zwosta

    US Agent

    Business Name
    Tosoh Bioscience Inc.
    Contact Name
    Isabelle Lang-Zwosta
    Address
    3600 Gantz Rd
    City
    Grove City
    State
    OH
    ZIP
    43123
    Country
    US
    Email
    [email protected]
    Phone
    615 8064671

    Products

    Device Name Product Code
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Acid, Folic, Radioimmunoassay CGN
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Calibrator, Primary JIS
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Ige, Antigen, Antiserum, Control DGC
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO
    System, Test, Thyroid Autoantibody JZO
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Fibrin Split Products GHH
    System, Test, Immunological, Antigen, Tumor MOI
    Ferritin, Antigen, Antiserum, Control DBF
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Calibrator, Secondary JIT
    Test, Natriuretic Peptide NBC
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    Diluent, Blood Cell GIF
    System, Test, Vitamin D MRG
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer LOJ
    Radioimmunoassay, Free Thyroxine CEC
    Fluorometric, Cortisol JFT
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Radioimmunoassay, Human Growth Hormone CFL
    Radioimmunoassay, Parathyroid Hormone CEW
    Radioimmunoassay, Progesterone JLS
    Test, Cystatin C NDY
    Radioimmunoassay, Total Triiodothyronine CDP
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Acid Phosphatase (Prostatic), Tartrate Inhibited JFH
    System, Test, Osteocalcin NEO
    System, Test, Beta-2-Microglobulin Immunological JZG
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF
    Radioimmunoassay, Acth CKG
    Fluorometric Method, Cpk Or Isoenzymes JHX
    Radioassay, Triiodothyronine Uptake KHQ
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG
    Visual, Pregnancy Hcg, Prescription Use JHI
    Radioassay, Vitamin B12 CDD
    General Purpose Reagent PPM
    Urinary Homocystine (Nonquantitative) Test System LPS
    Radioimmunoassay, Immunoreactive Insulin CFP
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions MTG
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM
    Immunoassay Method, Troponin Subunit MMI
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Radioimmunoassay, Luteinizing Hormone CEP
    Thyroglobulin, Antigen, Antiserum, Control DDC
    Radioimmunoassay, Estradiol CHP
    System, Test, Carcinoembryonic Antigen DHX
    System, Test, Thyroglobulin MSW
    Myoglobin, Antigen, Antiserum, Control DDR
    Test, Hiv Detection MZF
    System, Identification, Hepatitis B Antigen KSJ

    Proprietary Names

    AIA-PACK CA 125 Calibrator Set AIA-PACK CA 125 Sample Diluting Solution ST AIA-PACK CA 125 AIA-PACK RBC Folate Hemolyzing Reagent Set AIA-PACK RBC Folate Calibrator Set AIA-PACK RBC Folate Pretreatment Set AIA-PACK RBC Folate AIA-PACK RBC Folate Sample Diluting Reagent ST AIA-PACK FSH AIA-PACK FSH Sample Diluting Solution AIA-PACK FSH Calibrator Set CL AIA-PACK FSH Test Cup CL AIA-PACK FSH Adjuster Set AIA-PACK TSH 3rd-Gen Sample Diluting Solution ST AIA-PACK TSH AIA-PACK TSH 3rd-Gen AIA-PACK TSH 3rd-Gen Calibrator Set CL AIA-PACK CMV IgG Adjuster Set CL AIA-PACK CMV IgM Test Cup CL AIA-PACK CMV IgM Adjuster Set CL AIA-PACK CMV IgG Test Cup ST AIA-PACK C-Peptide II CL AIA-PACK C-Peptide Test Cup CL AIA-PACK C-Peptide Adjuster Set ST AIA-PACK C-Peptide II Sample Diluting Solution AIA-PACK IGE II CALIBRATOR SET, AIA-PACK IGE II SAMPLE DILUTING SOLUTION ST AIA-PACK IGEII CL AIA-PACK HCVAb Adjuster Set CL AIA-PACK HCVAb Test Cup CL AIA-PACK TPOAb Test Cup CL AIA-PACK TPOAb Adjuster Set CL AIA-PACK TgAb Test Cup CL AIA-PACK TgAb Adjuster Set CL AIA-PACK Toxo IgM Adjuster Set CL AIA-PACK Toxo IgG Test Cup CL AIA-PACK Toxo IgM Test Cup CL AIA-PACK Toxo IgG Adjuster Set ST AIA-PACK D-Dimer ST AIA-PACK D-Dimer Control Set ST AIA-PACK D-Dimer Sample Diluting Solution CL AIA-PACK D-Dimer Test Cup CL AIA-PACK D-Dimer Adjuster Set ST AIA-PACK D-Dimer Calibrator Set ST AIA-PACK CA 15-3 Calibrator Set ST AIA-PACK CA 15-3 Sample Diluting Solution CL AIA-PACK 27.29 Adjuster Set CL AIA-PACK 27.29 Test Cup ST AIA-PACK CA 15-3 ST AIA-PACK FER AIA-PACK FER Calibrator Set AIA-PACK FER Sample Diluting Solution ST AIA-PACK DHEA-S Sample Diluting Solution CL AIA-PACK DHEA-S Adjuster Set CL AIA-PACK DHEA-S Test Cup ST AIA- PACK DHEA-S CL AIA-PACK Prolactin II Test Cup ST AIA-PACK PRL AIA-PACK PRL Calibrator Set AIA-PACK PRL Sample Diluting Solution CL AIA-PACK Prolactin II Adjuster Set ST AIA-PACK C-Peptide II Calibrator Set ST AIA-PACK BNP CL AIA-PACK BNP Test Cup ST AIA-PACK BNP Calibrator Set CL AIA-PACK BNP Adjuster Set ST AIA-PACK BNP Sample Diluting Solution ST AIA-PACK BNP Control Set ST AIA-PACK Progesterone III Calibrator Set CL AIA-PACK Rubella IgM Adjuster Set CL AIA-PACK Rubella IgM Test Cup CL AIA-PACK Rubella IgG Test Cup CL AIA-PACK Rubella IgG Adjuster Set CL AIA-PACK Folate Adjuster Set CL AIA-PACK Folate Pretreatment Cup CL AIA-PACK Folate Test Cup CL AIA-PACK Sample Diluting Reagent F CL AIA-PACK Progesterone Sample Diluting Reagent CL AIA-PACK Cortisol Sample Diluting Reagent CL AIA-PACK Sample Diluting Reagent B CL AIA-PACK Sample Diluting Reagent D CL AIA-PACK Sample Diluting Reagent I CL AIA-PACK Sample Diluting Reagent E CL AIA-PACK Sample Diluting Reagent C CL AIA-PACK HCVAb Sample Diluting Reagent CL AIA-PACK Sample Diluting Reagent A CL AIA-PACK Sample Diluting Reagent G CL AIA-PACK 25-OH Vitamin D Adjuster Set CL AIA-PACK 25-OH Vitamin D Pretreatment Cup CL AIA-PACK 25-OH Vitamin D Test Cup AIA-PACK C-Peptide Control Set CL AIA-PACK AFP Test Cup CL AIA-PACK AFP Adjuster Set ST AIA-PACK FT4 AIA-PACK FT4 Calibrator Set CL AIA-PACK Cortisol Adjuster Set CL AIA-PACK Cortisol Test Cup ST AIA-PACK Free PSA Sample Diluting Solution ST AIA-PACK PSA II ST AIA-PACK Free PSA Calibrator Set ST AIA-PACK PSA II Sample Diluting Solution ST AIA-PACK PSA II Calibrator Set ST AIA-PACK Free PSA CL AIA PACK FT4 Adjuster Set CL AIA PACK FT4 Test Cup ST AIA-PACK HGH Sample Diluting Solution ST AIA-PACK HGH Calibrator Set ST AIA-PACK HGH ST AIA-PACK Intact PTH Calibrator Set ST AIA-PACK Intact PTH ST AIA-PACK Intact PTH Sample Diluting Solution AIA-PACK Intact PTH Control Set ST AIA-PACK Progesterone III Sample Diluting Solution CL AIA-PACK Progesterone Adjuster Set ST AIA-PACK Progesterone III CL AIA-PACK Progesterone Test Cup ST AIA PACK Cystatin C Calibrator Set ST AIA PACK Cystatin C ST AIA PACK Cystatin C Sample Diluting Solution AIA-PACK Cystatin C Control Set AIA-PACK TT3 Sample Diluting Solution ST AIA-PACK TT3 AIA-PACK TT3 Calibrator Set AIA-PACK AFP Calibration Verification Test Set AIA-PACK TgAb AIA-PACK TgAb Calibrator Set AIA-PACK TgAb Control Set ST AIA-PACK TESTOSTERONE Sample Diluting Solution ST AIA-PACK TESTOSTERONE ST AIA-PACK TESTOSTERONE Calibrator Set AIA-PACK PAP Calibrator Set ST AIA-PACK PAP AIA-PACK PAP Sample Diluting Solution CL AIA-PACK IgE Test Cup CL AIA-PACK IgE Adjuster Set ST AIA-PACK Osteocalcin ST AIA-PACK Osteocalcin Sample Diluting Solution ST AIA-PACK Osteocalcin Calibrator Set ST AIA-PACK Osteocalcin Control Set AIA-PACK BMG Calibrator Set ST AIA-PACK BMG AIA-PACK BMG Sample Diluting Solution CL AIA-PACK PSA Adjuster Set CL AIA-PACK PSA Test Cup CL AIA-PACK ACTH Test Cup CL AIA-PACK ACTH Adjuster Set ST AIA-PACK CK-MB AIA-PACK CK-MB Sample Diluting Solution AIA-PACK CK-MB Calibrator Set AIA-PACK T-U Calibrator Set ST AIA-PACK T-U ST AIA-PACK 27.29 AIA-PACK 27.29 Calibrator Set AIA-PACK 27.29 Sample Diluting Solution CL AIA-PACK CA 19-9 Test Cup CL AIA-PACK CA 19-9 Adjuster Set ST AIA-PACK hsE2 Calibrator Set ST AIA-PACK ?HCG II ST AIA-PACK ?HCG II Calibrator Set ST AIA-PACK ?HCG II Sample Diluting Solution CL AIA-PACK ?HCG Adjuster Set CL AIA-PACK ?HCG Test Cup AIA-PACK ?HCG Calibration Verification Test Set CL AIA-PACK Vitamin B12 Pretreatment Reagent-1 CL AIA-PACK Vitamin B12 Adjuster Set CL AIA-PACK Vitamin B12 Pretreatment Reagent-2 CL AIA-PACK Vitamin B12 Test Cup AIA-PACK Substrate Set II CL AIA-PACK Diluent Concentrate(60 mL) CL AIA-PACK Substrate Set (100 mL) AIA-PACK Diluent Concentrate AIA-PACK Wash Concentrate CL AIA-PACK Substrate Set (50 mL) CL AIA-PACK Wash Concentrate CL AIA-PACK Detector Standardization Cup CL AIA-PACK Substrate Set (Cups) CL AIA-PACK Diluent Concentrate (100 mL) CL AIA-PACK Intact PTH Adjuster Set CL AIA-PACK Intact PTH Test Cup ST AIA-PACK Progesterone II Calibrator Set ST AIA-PACK cTnI 3rd-Gen Calibrator Set ST AIA-PACK SHBG Sample Diluting Solution ST AIA-PACK SHBG Calibrator Set AIA-PACK SHBG Control Set ST AIA-PACK SHBG AIA-PACK TPOAB/TgAb Sample diluting solution AIA-PACK TPOAB Control Set AIA-PACK TPOAB Calibrator Set AIA-PACK TPOAB ST AIA-PACK 25-OH Vitamin D Pretreatment Set AIA-PACK 25-OH Vitamin D Control Set ST AIA-PACK 25-OH Vitamin D Calibrator Set ST AIA-PACK 25-OH Vitamin D AIA-PACK FOLATE Pretreatment Set AIA-PACK FOLATE AIA-PACK FOLATE Calibrator Set AIA-PACK FOLATE Sample Diluting Solution CL AIA-PACK Testosterone Test Cup CL AIA-PACK Testosterone Adjuster Set ST AIA-PACK Homocysteine Pretreatment Set ST AIA-PACK Homocysteine Calibrator Set AIA-PACK Homocysteine Control Set ST AIA-PACK Homocysteine ST AIA-PACK Homocysteine Sample Diluting Solution AIA-PACK PAP Calibration Verification Test Set AIA-PACK IRI Calibrator Set AIA-PACK IRI Sample Diluting Solution ST AIA-PACK IRI AIA-PACK IRI Control Set CL AIA-PACK FT3 Test Cup CL AIA-PACK T3 Adjuster Set CL AIA-PACK FT3 Adjuster Set CL AIA-PACK T3 Test Cup AIA-PACK B12 CALIBRATOR SET,AIA-PACK B12 SAMPLE DILUTING SOLUTION,AIA-PACK B12 PRETREATMENT SET AIA-PACK B12 ST AIA-PACK CA 19-9 AIA-PACK CA 19-9 Calibrator Set AIA-PACK CA 19-9 Sample Diluting Solution ST AIA-PACK T4 AIA-PACK T4 Sample Diluting Solution AIA-PACK T4 Calibrator Set AIA-PACK ?HCG Sample Diluting Solution AIA-PACK ?HCG Calibrator Set ST AIA-PACK ?HCG CL AIA PACK TSH Test Cup CL AIA-PACK TSH Adjuster Set CL AIA-PACK FREE PSA Adjuster Set CL AIA-PACK FREE PSA Test Cup CL AIA-PACK T4 Adjuster Set CL AIA-PACK T4 Test Cup AIA-PACK HBeAg Sample Diluting Solution AIA-PACK HBcAb Calibrator Set CL AIA-PACK HBcAb Adjuster Set CL AIA-PACK HBeAg Test Cup AIA-PACK HBcAb Sample Diluting Solution ST AIA-PACK HBeAb AIA-PACK HBeAb Calibrator Set CL AIA-PACK HBeAb Adjuster Set AIA-PACK HBV Antigen Control Set CL AIA-PACK HBeAg Adjuster Set CL AIA-PACK HBcAb Test Cup CL AIA-PACK HBeAb Test Cup AIA-PACK HBV Antibody Control Set ST AIA-PACK HBeAg AIA-PACK HBeAg Calibrator Set ST AIA-PACK HBcAb CL AIA-PACK CK-MB Test Cup CL AIA-PACK CK-MB Adjuster Set ST AIA-PACK ACTH ST AIA-PACK ACTH Calibrator Set ST AIA-PACK ACTH Sample Diluting Solution AIA-PACK ACTH Control Set ST AIA-PACK cTnI 3rd-Gen Sample Diluting Solution CL AIA-PACK cTnI Test Cup ST AIA-PACK cTnI 3rd-Gen CL AIA-PACK cTnI Adjuster Set ST AIA-PACK cTnI 2nd-Gen Sample Diluting Solution ST AIA-PACK cTnI 2nd-Gen ST AIA-PACK cTnI 2nd-Gen Calibrator Set ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION ST AIA-PACK AFP AIA-PACK HCG Sample Diluting Solution ST AIA-PACK HCG AIA-PACK HCG Calibrator Set ST AIA-PACK Progesterone II Sample Diluting Solution ST AIA-PACK Progesterone II ST AIA-PACK DHEA-S Calibrator Set ST AIA-PACK LH II ST AIA-PACK LH II Calibrator Set ST AIA-PACK LH II Sample Diluting Solution CL AIA-PACK LH Test Cup CL AIA-PACK LH Adjuster Set AIA-PACK Thyroglobulin Control Set AIA-PACK FER Calibration Verification Test Set CL AIA-PACK CA 125 Adjuster Set CL AIA-PACK CA 125 Test Cup AIA-PACK FSH Calibration Verification Test Set CL AIA-PACK hs-E2 Test Cup ST AIA-PACK hs-E2 ST AIA-PACK E2 Sample Diluting Solution ST AIA-PACK hsE2 Sample Diluting Solution CL AIA-PACK hs-E2 Adjuster Set ST AIA-PACK E2 ST AIA-PACK E2 Calibrator Set ST AIA-PACK CEA AIA-PACK CEA Calibrator Set AIA-PACK CEA Sample Diluting Solution CL AIA-PACK Thyroglobulin Adjuster Set ST AIA-PACK Thyroglobulin Calibrator Set ST AIA-PACK Thyroglobulin ST AIA-PACK Thyroglobulin Sample Diluting Solution CL AIA-PACK Thyroglobulin Test Cup AIA-PACK PA Calibration Verification Test Set AIA-PACK CEA Calibration Verification Test Set CL AIA-PACK CEA Test Cup CL AIA-PACK CEA Adjuster Set ST AIA-PACK FT3 AIA-PACK FT3 Calibrator Set CL AIA-PACK ?2-Microglobulin Adjuster Set CL AIA-PACK ?2-Microglobulin Test Cup ST AIA-PACK MYOGLOBIN ST AIA-PACK MYOGLOBIN Sample Diluting Solution ST AIA-PACK MYOGLOBIN Calibrator Set AIA-PACK PSA Calibrator Set ST AIA-PACK PSA AIA-PACK PSA Sample Diluting Solution CL AIA-PACK HIV Ag/Ab Test Cup CL AIA-PACK HIV Ag/Ab Adjuster Set CL AIA-PACK HIV Ag/Ab Control Set AIA-PACK PRL Calibration Verification Test Set CL AIA-PACK Ferritin Test Cup CL AIA-PACK Ferritin Adjuster Set AIA-PACK HBsAg Sample Diluting Solution CL AIA-PACK HBsAg Adjuster Set ST AIA-PACK HBsAb AIA-PACK HBsAb Calibrator Set CL AIA-PACK HBsAb Test Cup AIA-PACK HBsAb Sample Diluting Solution ST AIA-PACK HBsAg CL AIA-PACK HBsAg Test Cup AIA-PACK HBsAg Calibrator Set CL AIA-PACK HBsAb Adjuster Set ST AIA-PACK CORT AIA-PACK CORT Calibrator Set AIA-PACK CORT Sample Diluting Solution

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device