Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031673

FEI Number

2967

Entity Name

TOSOH CORP.

City/State/Country

Chuo-ku Tokyo, JP

Establishment Address

2-2-1 Yaesu, Chuo-ku Tokyo 104-0028, JP

Establishment Type(s)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

AIA-PACK ?HCG Calibration Verification Test Set ST AIA-PACK Progesterone III Calibrator Set CL AIA-PACK AFP Test Cup CL AIA-PACK AFP Adjuster Set HLC-723 GR01 Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 GR01 AIA-PACK BMG Calibrator Set ST AIA-PACK BMG AIA-PACK BMG 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 CL AIA-PACK IgE Test Cup CL AIA-PACK IgE Adjuster Set ST AIA-PACK Progesterone II Sample Diluting Solution ST AIA-PACK Progesterone II ST AIA-PACK HGH Sample Diluting Solution ST AIA-PACK HGH Calibrator Set ST AIA-PACK HGH ST AIA-PACK DHEA-S Calibrator Set AIA-PACK PRL Calibration Verification Test Set CL AIA-PACK CA 125 Adjuster Set CL AIA-PACK CA 125 Test Cup ST AIA-PACK SHBG Sample Diluting Solution ST AIA-PACK SHBG Calibrator Set AIA-PACK SHBG Control Set ST AIA-PACK SHBG 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 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 AIA-PACK AFP Calibration Verification Test 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 PSA Calibrator Set ST AIA-PACK PSA AIA-PACK PSA Sample Diluting Solution ST AIA-PACK BNP ST AIA-PACK BNP Control Set ST AIA-PACK BNP Sample Diluting Solution ST AIA-PACK BNP Calibrator 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) ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION ST AIA-PACK AFP ST AIA-PACK CEA AIA-PACK CEA Calibrator Set AIA-PACK CEA Sample Diluting Solution 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 PA Calibration Verification Test Set ST AIA-PACK FER AIA-PACK FER Calibrator Set AIA-PACK FER Sample Diluting Solution ST AIA-PACK 25-OH Vitamin D AIA-PACK 25-OH Vitamin D Control Set ST AIA-PACK 25-OH Vitamin D Calibrator Set ST AIA-PACK 25-OH Vitamin D Pretreatment Set Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA G8 F&A2 Calibrator Set TSKgel G8 ?-thal HLC-723G8 G8 90 SL G8 ?-thal Elution Buffer Kit CL AIA PACK FT4 Adjuster Set CL AIA PACK FT4 Test Cup CL AIA-PACK CA 19-9 Test Cup CL AIA-PACK CA 19-9 Adjuster Set AIA-PACK TPOAB/TgAb Sample diluting solution AIA-PACK TPOAB Control Set AIA-PACK TPOAB Calibrator Set AIA-PACK TPOAB 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 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 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 AIA-PACK CEA Calibration Verification Test Set ST AIA-PACK 27.29 AIA-PACK 27.29 Calibrator Set AIA-PACK 27.29 Sample Diluting Solution AIA-PACK TgAb AIA-PACK TgAb Calibrator Set AIA-PACK TgAb Control Set ST AIA-PACK cTnI 3rd-Gen Calibrator Set CL AIA-PACK Ferritin Test Cup CL AIA-PACK Ferritin Adjuster Set AIA-PACK FER Calibration Verification Test 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 T-U Calibrator Set ST AIA-PACK T-U 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 AIA-PACK CA 125 Calibrator Set AIA-PACK CA 125 Sample Diluting Solution ST AIA-PACK CA 125 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 TESTOSTERONE Sample Diluting Solution ST AIA-PACK TESTOSTERONE ST AIA-PACK TESTOSTERONE Calibrator Set ST AIA-PACK T4 AIA-PACK T4 Sample Diluting Solution AIA-PACK T4 Calibrator Set CL AIA-PACK CEA Test Cup CL AIA-PACK CEA Adjuster Set AIA-PACK HCG Sample Diluting Solution ST AIA-PACK HCG AIA-PACK HCG Calibrator Set ST AIA-PACK FT3 AIA-PACK FT3 Calibrator Set AIA-PACK ?HCG Sample Diluting Solution AIA-PACK ?HCG Calibrator Set ST AIA-PACK ?HCG CL AIA-PACK HCVAb Adjuster Set CL AIA-PACK HCVAb Test Cup AIA-PACK C-Peptide Control Set 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 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 CORT AIA-PACK CORT Calibrator Set AIA-PACK CORT Sample Diluting Solution ST AIA-PACK C-Peptide II Calibrator Set CL AIA-PACK T4 Adjuster Set CL AIA-PACK T4 Test Cup AIA-PACK IRI Calibrator Set AIA-PACK IRI Sample Diluting Solution ST AIA-PACK IRI AIA-PACK IRI Control Set AIA-PACK PAP Calibration Verification Test Set AIA-PACK TT3 Sample Diluting Solution ST AIA-PACK TT3 AIA-PACK TT3 Calibrator Set Automated Immunoassay Analyzer AIA-2000 Automated Immunoassay Analyzer AIA-360 Automated Immunoassay Analyzer AIA-900 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 CL AIA-PACK ACTH Test Cup CL AIA-PACK ACTH Adjuster Set CL AIA-PACK PSA Adjuster Set CL AIA-PACK PSA Test Cup AIA-PACK FOLATE Pretreatment Set AIA-PACK FOLATE AIA-PACK FOLATE Calibrator Set AIA-PACK FOLATE Sample Diluting Solution TSKgel GX HLC-723GX GX Elution Buffer No. 1 GX Elution Buffer No. 2 Tosoh Automated Glycohemoglobin Analyzer HLC-723GX GX Elution Buffer No. 3 CL AIA-PACK Cortisol Adjuster Set CL AIA-PACK Cortisol Test Cup 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 CL AIA-PACK Testosterone Test Cup CL AIA-PACK Testosterone Adjuster Set ST AIA-PACK FT4 AIA-PACK FT4 Calibrator Set 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 AIA®-CL300 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER AIA®-CL2400 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER AIA®-CL1200 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER 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 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 CL AIA-PACK CK-MB Test Cup CL AIA-PACK CK-MB Adjuster Set ST AIA-PACK CK-MB AIA-PACK CK-MB Sample Diluting Solution AIA-PACK CK-MB Calibrator Set AIA-PACK Thyroglobulin Control Set ST AIA-PACK MYOGLOBIN ST AIA-PACK MYOGLOBIN Sample Diluting Solution ST AIA-PACK MYOGLOBIN Calibrator 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 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 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 TSH Test Cup CL AIA-PACK TSH Adjuster Set ST AIA-PACK CA 19-9 AIA-PACK CA 19-9 Calibrator Set AIA-PACK CA 19-9 Sample Diluting Solution AIA-PACK T-U Calibrator Set ST AIA-PACK T-U CL AIA-PACK Folate Adjuster Set CL AIA-PACK Folate Pretreatment Cup CL AIA-PACK Folate Test Cup AIA-PACK FSH Calibration Verification Test Set HEMOGLOBIN A1c Control SET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-07-08
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2025-04-14
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
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2005-11-14
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
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2025-04-14
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2014-12-05
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2005-05-20
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2025-04-14
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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2017-06-13
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2025-07-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
NEO	System, Test, Osteocalcin	Clinical Chemistry	Class 2	862.1050	2017-09-13
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2008-12-03
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2008-12-03
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2020-12-16
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-07-08
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2005-11-14
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2005-11-14
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
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2009-05-22
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2019-06-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-06-11
JPD	Hemoglobin A2 Quantitation	Hematology	Class 2	864.7400	2017-02-07
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-03-14
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2025-04-14
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2005-11-14
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
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2017-04-18
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2024-03-14
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2009-05-29
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2005-11-14
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2009-05-29
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-04-19
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2025-04-14
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2009-05-08
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2017-04-19
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2005-11-14
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1994-04-20
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2005-11-14
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1994-04-04
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2005-11-14
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2009-05-11
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2024-03-14
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2010-03-18
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2009-05-27
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2005-11-14
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2026-04-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-17
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2017-04-19
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2009-10-15
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2005-11-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-08-11
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2025-04-14
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2005-05-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-05-26
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2009-05-26
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2005-11-14
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2017-06-12
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2025-04-14
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2024-03-14
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2005-11-14
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2017-02-07
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2025-04-14
KSJ	System, Identification, Hepatitis B Antigen	Unknown	Class 3	N/A	2017-04-18
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2025-04-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2005-11-14
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2017-04-18
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-05-09
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2005-11-14
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2017-01-30
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2025-04-14
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2005-11-14
DDC	Thyroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5870	2017-06-12
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2005-11-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-06-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-06-19
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2012-06-19
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1994-09-02
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2026-04-27
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-03-14
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
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2005-05-20
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2025-05-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-03-15

Official Correspondent

Isabelle Lang-Zwosta

US Agent Details

Isabelle Lang-Zwosta Business: Tosoh Bioscience Inc. Email: Isabelle.Lang-Zwosta@Tosoh.com Phone: (615) 8064671

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
9612316	TOSOH AIA, INC.	TOYAMA, JP
3005529799	TOSOH BIOSCIENCE, INC.	Grove City, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031673. Last updated year: 2026. Please use registration number 8031673 when referencing this establishment in official correspondence.