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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 3 of 8

Device	Model / Reference	Registries	Class	Status
St Aia-Pack Hcgii	0025219	EUDAMED	IVD General	Active
G11 Elution Buffer No. 3 (S)	0023858	EUDAMED	IVD General	Active
GX Elution Buffer No. 1 (S)	0023510	EUDAMED	IVD General	Active
G7 β-Thalassemia Elution Buffer Kit	0021472	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK IgE TEST CUP	0029143	EUDAMED	IVD General	Active
CL AIA-PACK SARS-CoV-2-Ag TEST CUP	0029174	EUDAMED	IVD General	Active
St Aia-Pack Ft4	0025268	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK D-Dimer CONTROL SET	0025432	EUDAMED	IVD General	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723G11	0023850	EUDAMED	Class A	Active
Cl Aia-Pack 27.29 Adjuster Set	0029211	EUDAMED	IVD General	Active
St Aia-Pack Kl-6 Sample Diluting Solution	0025544	EUDAMED	IVD General	Active
Cl Aia-Pack Detector Standardization Cup	0029705	EUDAMED	Class A	Active
Aia-Pack Afp Sample Diluting Solution	0020552	EUDAMEDFDA UDI	IVD General	Active
G11 Variant Elution Buffer No. 1 (S)	0023479	EUDAMED	IVD General	Active
Aia-Pack Folate	0020292	EUDAMED	IVD General	Active
G8 Elution Buffer HSi No.2 (S)	0021801	EUDAMED	IVD General	Active
G11 Variant Elution Buffer No. 2 (S)	0023480	EUDAMED	IVD General	Active
CL AIA-PACK Vitamin B12 PRETREATMENT REAGENT-1	0029567	EUDAMED	IVD General	Active
CL AIA-PACK Osteocalcin ADJUSTER SET	0029254	EUDAMED	IVD General	Active
Aia-Pack Detector Standardization Test Cup	0020970	EUDAMED	Class A	Active
Aia-Pack Rbc Folate Hemolyzing Reagent Set	0020711	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Ft4 Calibrator Set	0020368	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Ovca Calibrator Set	0020389	EUDAMED	IVD General	Active
AIA-PACK TgAb CONTROL SET	0025491	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Presepsin TEST CUP	0029166	EUDAMED	IVD General	Active
Aia-Pack B12 Sample Diluting Solution	0020593	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Bnp Adjuster Set	0029209	EUDAMED	IVD General	Active
CL AIA-PACK 25-OH Vitamin D PRETREATMENT CUP	0029546	EUDAMED	IVD General	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723GX	0023130	EUDAMED	Class A	Active
CL AIA-PACK SARS-CoV-2-Ab CONTROL SET	0029710	EUDAMED	IVD General	Active
AIA-PACK TSH 3rd-Gen SAMPLE DILUTING SOLUTION	0020594	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Fer Calibrator Set	0020353	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack B12	0020293	EUDAMED	IVD General	Active
Hemoglobin F&A2 Calibrator	0020019	EUDAMEDFDA UDI	IVD General	Active
G11 β-Thalassemia Elution Buffer No. 2(S)	0023506	EUDAMED	IVD General	Active
Cl Aia-Pack Kl-6 Adjuster Set	0029258	EUDAMED	IVD General	Active
ST AIA-PACK Testosterone CALIBRATOR SET	0025304	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Thyroglobulin SAMPLE DILUTING SOLUTION	0025527	EUDAMED	IVD General	Active
Aia-Pack Rbc Folate Calibrator Set	0020314	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK iE2	0025224	EUDAMED	IVD General	Active
Hemoglobin A1c Calibrator Set	0018767	EUDAMEDFDA UDI	Class C	Active
Aia-Pack Tt3 Sample Diluting Solution	0020582	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack T4 Test Cup	0029105	EUDAMED	IVD General	Active
ST AIA-PACK hsE2 CALIBRATOR SET	0025325	EUDAMEDFDA UDI	IVD General	Active
TSKgel G11 Variant	0023478	EUDAMED	IVD General	Active
ST AIA-PACK Thyroglobulin CALIBRATOR SET	0025327	EUDAMED	IVD General	Active
St Aia-Pack Shbg Sample Diluting Solution	0025538	EUDAMEDFDA UDI	IVD General	Active
TRCR MB-Lysis Reagent	0056202	EUDAMED	IVD General	Active
TSKgel G7 HSi	0019551	EUDAMED	IVD General	Active
Aia-Pack Fsh Calibrator Set	0020365	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