Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005529799

FEI Number

3005529799

Entity Name

TOSOH BIOSCIENCE, INC.

City/State/Country

Grove City, OH, US

Establishment Address

3600 Gantz Rd, Grove City, OH 43123, US

Establishment Type(s)

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

Owner / Operator

TOSOH BIOSCIENCE (Owner Number: 8031673)

Owner / Operator Contact Address

3600 Gantz Road, Grove City, OH 43123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K972586

PMA Number

N/A

All Registered 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 G8 Variant Elution Buffer No. 3 HbA1c Calibrator Set G8 90 SL Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 TSKgel G8 Variant HLC-723G8 G8 Variant Elution Buffer No. 1 G8 Variant Elution Buffer No. 2 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 AIA-PACK T-U Calibrator Set ST AIA-PACK T-U 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2009-10-15
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2005-11-14
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2025-05-28
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2005-05-20
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2016-12-28
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2025-04-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-03-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-13
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-05-09
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2025-04-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-05-26
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2025-04-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-02-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-02-01
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2012-02-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-12-05
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2025-04-14
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2024-03-14
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2005-05-20
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2025-04-14
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2026-04-27
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2005-11-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2005-11-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2009-05-29
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2009-05-29
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2005-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2005-11-15
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2010-03-18
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2017-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-12-01
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-12-01
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2005-11-14
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-03-14
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2025-04-14
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2007-12-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-11
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2026-04-27
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2005-11-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-02-18
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2013-02-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-07-08
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2009-05-27
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2026-03-31
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2015-07-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-07-07
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-04-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-17
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2025-04-14
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2009-05-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2025-04-14
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2005-11-15
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2005-11-14
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2024-12-12
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1994-04-20
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-08-11
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2025-04-14
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2024-03-14
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	1997-05-07
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2025-04-14
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2009-05-08
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2005-11-14
MTG	Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	Unknown	Class 3	N/A	2024-03-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2025-12-29
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2025-12-29
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-09-16
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2010-09-16
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2005-11-14
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1994-09-02
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2005-05-20
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2005-11-14
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1994-04-04
JFH	Acid Phosphatase (Prostatic), Tartrate Inhibited	Clinical Chemistry	Class 2	862.1020	2009-05-29
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2009-05-29
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2005-11-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2005-11-14

Official Correspondent

Isabelle Lang-Zwosta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TOSOH BIOSCIENCE

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004529019	Tosoh Hi-Tec, Inc.	Yamaguchi, JP
8031673	TOSOH CORP.	Chuo-ku Tokyo, JP
9612316	TOSOH AIA, INC.	TOYAMA, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172201	Siemens Healthcare Diagnostics, Inc.	Atellica IM Folate Assay	2018-04-12
K171771	Siemens Healthcare Diagnostics, Inc.	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay	2017-12-04
K080167	Siemens Healthcare Diagnostics	ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS	2008-08-08
K140859	Siemens Healthcare Diagnostics, Inc.	DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT	2014-11-26
K083373	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 FREE T4	2009-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

Similar Registrations

Registration Number	Establishment Name	Location
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR
9612316	TOSOH AIA, INC.	TOYAMA, JP
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005529799. Last updated year: 2026. Please use registration number 3005529799 when referencing this establishment in official correspondence.