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Tosoh Corporation

Japan·JP-MF-000024143

Last updated May 27, 2026

What Tosoh Corporation makes

Tosoh Corporation manufactures automated immunoassay systems and related reagent kits for in vitro diagnostic testing. Their product line includes test cups, calibrator sets, pretreatment cups, and sample diluting solutions for detecting markers such as Toxoplasma IgM, homocysteine, cytomegalovirus IgM, human chorionic gonadotropin (βHCGII), thyroid hormones (TT3), and follicle-stimulating hormone (FSH). These devices are designed for use in clinical laboratories to support diagnostic evaluations in areas like infectious disease, endocrinology, and fertility testing.

The company’s diagnostic products are classified under EU regulations as Class A, Class B, Class C, and IVD Annex II List B devices, with some falling under the broader IVD General category. These products are registered in the EU’s eudamed database, ensuring compliance with European Union regulatory requirements. Tosoh Corporation is headquartered in Japan.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Japan
Address: 2-2-1 Yaesu, Tokyo, Japan
Website: tosoh.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 650-615-8134
PRRC Contact: Yutaka Tahara
EUDAMED SRN: JP-MF-000024143
FDA FEI Number: —
DUNS Number: 690571724

Catalogue (399)

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Device	Model / Reference	Registries	Class	Status
Aia-Pack Ck-Mb Calibrator Set	0020369	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Pivka-Ii Test Cup	0029144	EUDAMED	IVD General	Active
St Aia-Pack T4	0025258	EUDAMEDFDA UDI	IVD General	Active
G11 Elution Buffer No. 2 (S)	0023857	EUDAMED	IVD General	Active
TRCReady MTB	0056101	EUDAMED	IVD General	Active
G8 Variant Elution Buffer HSi No.3 (S)	0021851	EUDAMED	IVD General	Active
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200	0024131	EUDAMEDFDA UDI	Class A	Active
St Aia-Pack Progiii Calibrator Set	0025340	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Pivka-Ii Control Set	0025433	EUDAMED	IVD General	Active
St Aia-Pack Acth Sample Diluting Solution	0025521	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Bmg Sample Diluting Concentrate	0020559	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK IgE ADJUSTER SET	0029243	EUDAMED	IVD General	Active
Cl Aia-Pack T4 Adjuster Set	0029205	EUDAMED	IVD General	Active
St Aia-Pack 27.29	0025202	EUDAMED	IVD General	Active
Aia-Pack 27.29 Sample Diluting Solution	0020502	EUDAMED	IVD General	Active
Aia-Pack Iri Calibrator Set	0020360	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK TgAb CALIBRATOR SET	0020391	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Pap Calibrator Set	0020362	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Myoglobin TEST CUP	0029133	EUDAMED	IVD General	Active
HbA1c Diluting Solution	0023503	EUDAMED	IVD General	Active
St Aia-Pack Scc	0025237	EUDAMED	IVD General	Active
St Aia-Pack Hgh	0025266	EUDAMEDFDA UDI	IVD General	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA	0021674	EUDAMEDFDA UDI	Class A	Active
ST AIA-PACK Myoglobin CALIBRATOR SET	0025397	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Scc Control Set	0025437	EUDAMED	IVD General	Active
GX Assay Kit	0023161	EUDAMED	IVD General	Active
CL AIA-PACK 25-OH Vitamin D ADJUSTER SET	0029246	EUDAMED	IVD General	Active
Cl Aia-Pack Psa Test Cup	0029116	EUDAMED	IVD Annex II List B	Active
GX Elution Buffer No. 3 (S)	0023512	EUDAMED	IVD General	Active
St Aia-Pack Hcgii Calibrator Set	0025319	EUDAMED	IVD General	Active
G8 HbA1c Calibrator Set (S)	0023528	EUDAMED	IVD General	Active
Aia-Pack Cort Sample Diluting Solution	0020587	EUDAMEDFDA UDI	IVD General	Active
G11 Elution Buffer No. 1 (S)	0023856	EUDAMED	IVD General	Active
ST AIA-PACK iE2 SAMPLE DILUTING SOLUTION	0025524	EUDAMED	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent I	0029409	EUDAMED	Class A	Active
CL AIA-PACK free PSA ADJUSTER SET	0029217	EUDAMED	IVD Annex II List B	Active
CL AIA-PACK Anti-SARS-CoV-2-NP ADJUSTER SET	0029270	EUDAMED	IVD General	Active
St Aia-Pack Psaii	0025212	EUDAMED	IVD Annex II List B	Active
CL AIA-PACK β2-Microglobulin TEST CUP	0029141	EUDAMED	IVD General	Active
St Aia-Pack Lhii Calibrator Set	0025396	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Myoglobin ADJUSTER SET	0029233	EUDAMED	IVD General	Active
CL AIA-PACK Folate PRETREATMENT CUP	0029555	EUDAMED	IVD General	Active
Cl Aia-Pack Tsh Test Cup	0029101	EUDAMED	IVD General	Active
Cl Aia-Pack Ck-Mb Test Cup	0029134	EUDAMED	IVD General	Active
TSKgel G11	0023855	EUDAMED	IVD General	Active
CL AIA-PACK SARS-CoV-2-Ag CONTROL SET	0029374	EUDAMED	IVD General	Active
AIA-PACK TSH 3rd-Gen CALIBRATOR SET	0020394	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Substrate Set	0029701	EUDAMED	Class A	Active
Aia-Pack Kl-6 Control Set	0025444	EUDAMED	IVD General	Active
Cl Aia-Pack Lh Test Cup	0029124	EUDAMEDFDA UDI	IVD General	Active

Related Companies

Authorised Representatives

Tosoh Europe N.V. BE

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Tosoh Corp. US