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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)

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
Aia-Pack Prl Calibrator Set	0020355	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Folate / Vitamin B12 CONTROL SET	0029355	EUDAMED	IVD General	Active
Trcr Tip Set	0056301	EUDAMED	Class A	Active
G7 Variant Elution Buffer HSi No.3 (S)	0019554	EUDAMED	IVD General	Active
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200	0024130	EUDAMEDFDA UDI	Class A	Active
Cl Aia-Pack Ft3 Adjuster Set	0029202	EUDAMED	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent A	0029401	EUDAMEDFDA UDI	Class A	Active
St Aia-Pack Psaii Calibrator Set	0025312	EUDAMED	IVD Annex II List B	Active
St Aia-Pack Acth	0025221	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Vitamin B12 PRETREATMENT REAGENT-2	0029767	EUDAMED	IVD General	Active
Cl Aia-Pack Βhcg Test Cup	0029128	EUDAMED	IVD General	Active
St Aia-Pack Ck-Mb	0025269	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent Z	0029410	EUDAMED	IVD General	Active
St Aia-Pack Pivka-Ii Sample Diluting Solution	0025533	EUDAMED	IVD General	Active
CL AIA-PACK D-Dimer TEST CUP	0029142	EUDAMED	IVD General	Active
St Aia-Pack Bnp Sample Diluting Solution	0025528	EUDAMED	IVD General	Active
Aia-Pack Cort Calibrator Set	0020387	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Cea	0025254	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Thyroglobulin TEST CUP	0029106	EUDAMED	IVD General	Active
St Aia-Pack Cortii	0025246	EUDAMED	IVD General	Active
St Aia-Pack Fer	0025253	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK TgAb TEST CUP	0029119	EUDAMED	IVD General	Active
CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION	0029574	EUDAMED	IVD General	Active
St Aia-Pack Bmg	0025259	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Prl	0025255	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK free PSA CALIBRATOR SET	0025311	EUDAMED	IVD Annex II List B	Active
St Aia-Pack Progiii	0025240	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Rbc Folate Pretreatment Set	0020710	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Kl-6	0025244	EUDAMED	IVD General	Active
St Aia-Pack Hcgii Sample Diluting Solution	0025519	EUDAMED	IVD General	Active
ST AIA-PACK cTnI 3rd-Gen CALIBRATOR SET	0025315	EUDAMED	IVD General	Active
Cl Aia-Pack Cea Test Cup	0029108	EUDAMED	IVD General	Active
Cl Aia-Pack Substrate Set	0029709	EUDAMED	Class A	Active
AIA-PACK Cystatin C CONTROL SET	0025417	EUDAMED	IVD General	Active
Aia-Pack Folate Sample Diluting Solution	0020592	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK CMV IgG TEST CUP	0029157	EUDAMED	IVD Annex II List B	Active
Aia-Pack 27.29 Calibrator Set	0020302	EUDAMED	IVD General	Active
CL AIA-PACK Estradiol TEST CUP	0029121	EUDAMED	IVD General	Active
Aia-Pack Fer Sample Diluting Solution	0020553	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Psa Adjuster Set	0029216	EUDAMED	IVD Annex II List B	Active
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400	0023650	EUDAMEDFDA UDI	Class A	Active
CL AIA-PACK Vitamin B12 ADJUSTER SET	0029267	EUDAMED	IVD General	Active
ST AIA-PACK iE2 CALIBRATOR SET	0025324	EUDAMED	IVD General	Active
ST AIA-PACK Osteocalcin CALIBRATOR SET	0025336	EUDAMED	IVD General	Active
AIA-PACK TgAb	AIA-PACK TgAb	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Rubella IgG ADJUSTER SET	0029256	EUDAMED	IVD Annex II List B	Active
Cl Aia-Pack Acth Test Cup	0029145	EUDAMED	IVD General	Active
Cl Aia-Pack 27.29 Test Cup	0029111	EUDAMED	IVD General	Active
ST AIA-PACK D-Dimer SAMPLE DILUTING SOLUTION	0025532	EUDAMED	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