Is this your brand? Sign in to claim ownership.

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 6 of 8

Device	Model / Reference	Registries	Class	Status
G11 β-Thalassemia Elution Buffer No. 1(S)	0023505	EUDAMED	IVD General	Active
CL AIA-PACK Progesterone TEST CUP	0029122	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Iri Sample Diluting Solution	0020560	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent H	0029408	EUDAMED	IVD General	Active
CL AIA-PACK Testosterone ADJUSTER SET	0029230	EUDAMED	IVD General	Active
CL AIA-PACK Intact PTH TEST CUP	0029140	EUDAMED	IVD General	Active
ST AIA-PACK Intact PTH	0025213	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK free PSA	0025211	EUDAMED	IVD Annex II List B	Active
CL AIA-PACK Progesterone SAMPLE DILUTING REAGENT	0029422	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK C-Peptide TEST CUP	0029132	EUDAMED	IVD General	Active
St Aia-Pack Scc Sample Diluting Solution	0025537	EUDAMED	IVD General	Active
ST AIA-PACK IgEII	0025295	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack T4 Calibrator Set	0020358	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK D-Dimer CALIBRATOR SET	0025332	EUDAMED	IVD General	Active
ST AIA-PACK Homocysteine	0025226	EUDAMEDFDA UDI	IVD General	Active
TSKgel G8 HSi	0021498	EUDAMED	IVD General	Active
CL AIA-PACK TRAb CONTROL SET	0025416	EUDAMED	IVD General	Active
90 Sample Loader GR-90SL	0024752	EUDAMED	Class A	Active
Cl Aia-Pack Scc Adjuster Set	0029247	EUDAMED	IVD General	Active
ST AIA-PACK hsE2 SAMPLE DILUTING SOLUTION	0025525	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Folate TEST CUP	0029155	EUDAMED	IVD General	Active
Aia-Pack Hgh Calibrator Set	0020366	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK C-PeptideII	0025283	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Homocysteine SAMPLE DILUTING SOLUTION	0025526	EUDAMED	IVD General	Active
Aia-Pack Pap Sample Diluting Solution	0020562	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK C-Peptide ADJUSTER SET	0029232	EUDAMED	IVD General	Active
Aia-Pack Rbc Folate	0020214	EUDAMED	IVD General	Active
Cl Aia-Pack Iri Test Cup	0029131	EUDAMED	IVD General	Active
90 Sample Loader G8-90SL	0021561	EUDAMEDFDA UDI	Class A	Active
Cl Aia-Pack Ck-Mb Adjuster Set	0029234	EUDAMED	IVD General	Active
Cl Aia-Pack Kl-6 Test Cup	0029158	EUDAMED	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent D	0029404	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent F	0029406	EUDAMED	IVD General	Active
Cl Aia-Pack Fsh Test Cup	0029127	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Cea Adjuster Set	0029208	EUDAMED	IVD General	Active
ST AIA-PACK cTnI 3rd-Gen SAMPLE DILUTING SOLUTION	0025515	EUDAMED	IVD General	Active
G7 HSi Elution Buffer No.3 (S)	0019546	EUDAMED	IVD General	Active
St Aia-Pack Dhea-S	0025222	EUDAMEDFDA UDI	IVD General	Active
TSKgel G8 Variant HSi	0021848	EUDAMED	IVD General	Active
St Aia-Pack Cort	0025287	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Iri Adjuster Set	0029231	EUDAMED	IVD General	Active
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400	0023651	EUDAMEDFDA UDI	Class A	Active
CL AIA-PACK SLa ADJUSTER SET	0029213	EUDAMED	IVD General	Active
AIA-PACK TPOAb/TgAb SAMPLE DILUTING SOLUTION	0020590	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION	0025597	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Testosterone SAMPLE DILUTING REAGENT	0029430	EUDAMED	IVD General	Active
Aia-Pack Folate Pretreatment Set	0020707	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Cystatin C	0025217	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK SARS-CoV-2-Ag ADJUSTER SET	0029274	EUDAMED	IVD General	Active
GR01 Elution Buffer No. 3	0024758	EUDAMED	Class C	Active

Related Companies

Authorised Representatives

Tosoh Europe N.V. BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Tosoh Corp. US