Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612316

FEI Number

3002808328

Entity Name

TOSOH AIA, INC.

City/State/Country

TOYAMA, JP

Establishment Address

2, IWASEKOSHI-MACHI, TOYAMA 931-8510, JP

Establishment Type(s)

Manufacture 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

K111762

PMA Number

N/A

All Registered 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 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 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 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 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 TT3 Calibrator Set ST AIA-PACK TT3 AIA-PACK TT3 Sample Diluting Solution AIA-PACK B12 CALIBRATOR SET,AIA-PACK B12 SAMPLE DILUTING SOLUTION,AIA-PACK B12 PRETREATMENT SET AIA-PACK B12 AIA-PACK T-U Calibrator Set ST AIA-PACK T-U ST AIA-PACK CA 19-9 AIA-PACK CA 19-9 Calibrator Set AIA-PACK CA 19-9 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 ST AIA-PACK BNP ST AIA-PACK BNP Control Set ST AIA-PACK BNP Sample Diluting Solution ST AIA-PACK BNP Calibrator Set 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2005-11-14
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2009-10-15
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2005-11-14
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
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2026-04-27
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	1997-05-07
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2005-11-14
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2026-04-27
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-04-14
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2026-04-27
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2017-06-12
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2017-04-18
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2009-05-22
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2005-11-14
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2005-11-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-08-11
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2017-01-30
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-07-08
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2026-04-27
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2025-05-28
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2025-07-08
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2025-04-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-17
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2020-12-16
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2025-04-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2005-11-14
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2025-04-14
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2017-04-19
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-03-14
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2005-05-20
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
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1994-04-04
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
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2009-05-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2009-05-29
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2005-11-14
JFH	Acid Phosphatase (Prostatic), Tartrate Inhibited	Clinical Chemistry	Class 2	862.1020	2009-05-29
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2025-04-14
NEO	System, Test, Osteocalcin	Clinical Chemistry	Class 2	862.1050	2017-09-13
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2005-11-14
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2020-12-16
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2024-03-14
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2025-04-14
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2005-11-14
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2005-11-14
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2005-11-14
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2025-04-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-02-29
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2017-04-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-06-03
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2024-12-12
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-07-08
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2025-04-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-12-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-04-19
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	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
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2005-11-14
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2025-04-14
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-05-26
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2005-05-20
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1994-09-02
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2005-11-15
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2005-05-20
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
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
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2020-12-16
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2009-05-11
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2005-11-14
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-03-14
MTG	Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	Unknown	Class 3	N/A	2024-03-14
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2025-04-14
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2017-04-18
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2017-06-13
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
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
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2010-03-18
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2014-12-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-13

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
8031673	TOSOH CORP.	Chuo-ku Tokyo, JP
3005529799	TOSOH BIOSCIENCE, INC.	Grove City, OH, US

Related 510(k) Records

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K172201	Siemens Healthcare Diagnostics, Inc.	Atellica IM Folate Assay	2018-04-12
K833852	Syncor Intl. Corp.	FSH RIA	1984-01-13
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612316. Last updated year: 2026. Please use registration number 9612316 when referencing this establishment in official correspondence.