FDA Registration
Active
🇺🇸 United States
TOSOH BIOSCIENCE, INC.
Reg #: 3005529799
·
FEI: 3005529799
·
Expires 2026
Products
57
Proprietary Names
286
Establishment Types
3
Classifications
57
Registration Details
- Registration Name
- TOSOH BIOSCIENCE, INC.
- Registration Number
- 3005529799
- FEI Number
- 3005529799
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3600 Gantz Rd
- City
- Grove City
- State
- OH
- ZIP
- 43123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091332
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2009-10-15 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2005-11-14 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2005-05-20 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2016-12-28 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2025-04-14 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2024-03-14 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2012-12-13 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-05-09 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2025-04-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2009-05-26 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2025-04-14 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2012-02-01 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2025-04-14 |
| Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | MTF | Class 3 | Unknown | No | 2024-03-14 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2005-05-20 |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | Class 2 | Immunology | No | 2025-04-14 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2026-04-27 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2005-11-14 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2005-11-14 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2005-11-15 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2010-03-18 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2017-12-19 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2008-12-01 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2005-11-14 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2024-03-14 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2025-04-14 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2007-12-11 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2026-04-27 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2013-02-18 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2009-05-27 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2026-03-31 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2025-04-14 |
| Fluorometric, Cortisol | JFT | Class 2 | Clinical Chemistry | No | 2025-04-14 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2009-05-11 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2005-11-15 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 1994-04-20 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2025-04-14 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 1997-05-07 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2005-11-14 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2024-03-14 |
| Test, Cystatin C | NDY | Class 2 | Clinical Chemistry | No | 2010-09-16 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2005-11-14 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2005-05-20 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 1994-04-04 |
| Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH | Class 2 | Clinical Chemistry | No | 2009-05-29 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2014-12-05 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2025-04-14 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2005-11-14 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-07-08 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2026-04-27 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2026-04-27 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2005-11-14 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2008-12-03 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2005-11-14 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2020-12-16 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2025-07-08 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2012-06-19 |
Proprietary Names
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 MYOGLOBIN
ST AIA-PACK MYOGLOBIN Sample Diluting Solution
ST AIA-PACK MYOGLOBIN Calibrator Set
CL AIA-PACK Folate Adjuster Set
CL AIA-PACK Folate Pretreatment Cup
CL AIA-PACK Folate Test Cup
AIA-PACK IRI Calibrator Set
AIA-PACK IRI Sample Diluting Solution
ST AIA-PACK IRI
AIA-PACK IRI Control Set
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
G8 Variant Elution Buffer No. 1
G8 90 SL
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA
HLC-723G8
TSKgel G8 Variant
G8 Variant Elution Buffer No. 2
HbA1c Calibrator Set
G8 Variant Elution Buffer No. 3
CL AIA-PACK Testosterone Test Cup
CL AIA-PACK Testosterone Adjuster Set
CL AIA PACK FT4 Adjuster Set
CL AIA PACK FT4 Test Cup
ST AIA-PACK DHEA-S Calibrator Set
AIA®-CL300 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER
AIA®-CL2400 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER
AIA®-CL1200 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER
CL AIA-PACK CA 19-9 Test Cup
CL AIA-PACK CA 19-9 Adjuster Set
AIA-PACK PAP Calibration Verification Test Set
CL AIA-PACK CA 125 Adjuster Set
CL AIA-PACK CA 125 Test Cup
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 Progesterone II Calibrator Set
CL AIA-PACK CK-MB Test Cup
CL AIA-PACK CK-MB Adjuster Set
CL AIA-PACK PSA Adjuster Set
CL AIA-PACK PSA Test Cup
AIA-PACK T-U Calibrator Set
ST AIA-PACK T-U
CL AIA-PACK AFP Test Cup
CL AIA-PACK AFP Adjuster 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 CEA
AIA-PACK CEA Calibrator Set
AIA-PACK CEA Sample Diluting Solution
ST AIA-PACK CA 19-9
AIA-PACK CA 19-9 Calibrator Set
AIA-PACK CA 19-9 Sample Diluting Solution
ST AIA-PACK cTnI 2nd-Gen Sample Diluting Solution
ST AIA-PACK cTnI 2nd-Gen
ST AIA-PACK cTnI 2nd-Gen Calibrator Set
AIA-PACK HCG Sample Diluting Solution
ST AIA-PACK HCG
AIA-PACK HCG Calibrator Set
HSi Hemolysis and Wash Solution (L)
AIA-PACK PA Calibration Verification Test Set
Automated Immunoassay Analyzer AIA-2000
Automated Immunoassay Analyzer AIA-360
Automated Immunoassay Analyzer AIA-900
CL AIA PACK TSH Test Cup
CL AIA-PACK TSH Adjuster Set
CL AIA-PACK IgE Test Cup
CL AIA-PACK IgE Adjuster Set
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
CL AIA-PACK HCVAb Adjuster Set
CL AIA-PACK HCVAb Test Cup
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
ST AIA-PACK Progesterone III Calibrator Set
ST AIA-PACK FT3
AIA-PACK FT3 Calibrator Set
CL AIA-PACK HIV Ag/Ab Test Cup
CL AIA-PACK HIV Ag/Ab Adjuster Set
CL AIA-PACK HIV Ag/Ab Control Set
ST AIA-PACK SHBG Sample Diluting Solution
ST AIA-PACK SHBG Calibrator Set
AIA-PACK SHBG Control Set
ST AIA-PACK SHBG
CL AIA-PACK TPOAb Test Cup
CL AIA-PACK TPOAb Adjuster Set
CL AIA-PACK TgAb Test Cup
CL AIA-PACK TgAb Adjuster Set
AIA-PACK C-Peptide Control Set
CL AIA-PACK Cortisol Adjuster Set
CL AIA-PACK Cortisol Test Cup
ST AIA-PACK T4
AIA-PACK T4 Sample Diluting Solution
AIA-PACK T4 Calibrator Set
AIA-PACK AFP Calibration Verification Test Set
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 B12 CALIBRATOR SET,AIA-PACK B12 SAMPLE DILUTING SOLUTION,AIA-PACK B12 PRETREATMENT SET
AIA-PACK B12
ST AIA-PACK CK-MB
AIA-PACK CK-MB Sample Diluting Solution
AIA-PACK CK-MB Calibrator 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
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 C-Peptide II Calibrator Set
CL AIA-PACK Ferritin Test Cup
CL AIA-PACK Ferritin Adjuster Set
CL AIA-PACK CEA Test Cup
CL AIA-PACK CEA Adjuster Set
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
CL AIA-PACK Intact PTH Adjuster Set
CL AIA-PACK Intact PTH Test Cup
AIA-PACK FER Calibration Verification Test Set
ST AIA-PACK 27.29
AIA-PACK 27.29 Calibrator Set
AIA-PACK 27.29 Sample Diluting Solution
CL AIA-PACK FREE PSA Adjuster Set
CL AIA-PACK FREE PSA Test Cup
AIA-PACK PRL Calibration Verification Test Set
HLC-723 GR01
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
GR01
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
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 FT3 Test Cup
CL AIA-PACK T3 Adjuster Set
CL AIA-PACK FT3 Adjuster Set
CL AIA-PACK T3 Test Cup
AIA-PACK TT3 Calibrator Set
ST AIA-PACK TT3
AIA-PACK TT3 Sample Diluting Solution
ST AIA-PACK HGH Sample Diluting Solution
ST AIA-PACK HGH Calibrator Set
ST AIA-PACK HGH
ST AIA-PACK CORT
AIA-PACK CORT Calibrator Set
AIA-PACK CORT Sample Diluting Solution
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
AIA-PACK PAP Calibrator Set
ST AIA-PACK PAP
AIA-PACK PAP Sample Diluting Solution
AIA-PACK TgAb
AIA-PACK TgAb Calibrator Set
AIA-PACK TgAb Control 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
ST AIA-PACK Progesterone II Sample Diluting Solution
ST AIA-PACK Progesterone II
CL AIA-PACK ?2-Microglobulin Adjuster Set
CL AIA-PACK ?2-Microglobulin Test Cup
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 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)
AIA-PACK ?HCG Calibration Verification Test Set
ST AIA-PACK FER
AIA-PACK FER Calibrator Set
AIA-PACK FER Sample Diluting Solution
ST AIA-PACK TESTOSTERONE Sample Diluting Solution
ST AIA-PACK TESTOSTERONE
ST AIA-PACK TESTOSTERONE Calibrator Set
AIA-PACK BMG Calibrator Set
ST AIA-PACK BMG
AIA-PACK BMG Sample Diluting Solution
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 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
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
CL AIA-PACK ACTH Test Cup
CL AIA-PACK ACTH Adjuster Set
ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION
ST AIA-PACK AFP
AIA-PACK TPOAB/TgAb Sample diluting solution
AIA-PACK TPOAB Control Set
AIA-PACK TPOAB Calibrator Set
AIA-PACK TPOAB
ST AIA-PACK FT4
AIA-PACK FT4 Calibrator Set
AIA-PACK CA 125 Calibrator Set
AIA-PACK CA 125 Sample Diluting Solution
ST AIA-PACK CA 125
AIA-PACK FOLATE Pretreatment Set
AIA-PACK FOLATE
AIA-PACK FOLATE Calibrator Set
AIA-PACK FOLATE Sample Diluting Solution
AIA-PACK CEA Calibration Verification Test Set
AIA-PACK PSA Calibrator Set
ST AIA-PACK PSA
AIA-PACK PSA Sample Diluting Solution
AIA-PACK IGE II CALIBRATOR SET, AIA-PACK IGE II SAMPLE DILUTING SOLUTION
ST AIA-PACK IGEII
AIA-PACK ?HCG Sample Diluting Solution
AIA-PACK ?HCG Calibrator Set
ST AIA-PACK ?HCG
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
ST AIA-PACK hsE2 Calibrator Set
AIA-PACK FSH Calibration Verification Test Set
ST AIA-PACK BNP
ST AIA-PACK BNP Control Set
ST AIA-PACK BNP Sample Diluting Solution
ST AIA-PACK BNP Calibrator Set
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
G11 Variant Elution Buffer No. 3
Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 LA
G11 Variant Elution Buffer No. 1
Tosoh Automated Glycohemoglobin Analyzer HLC-723G11
HLC-723G11
TSKgel G11 Variant
G11 90 SL
G11 Variant Elution Buffer No. 2
CL AIA-PACK T4 Adjuster Set
CL AIA-PACK T4 Test Cup
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
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device