Data from EUDAMED, last updated Jun 11, 2026

ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST

B-06936155804528

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: InTec PRODUCTS, INC.

Device family identification

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentProfessional testingAnimal tissues / cells

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

Data from EUDAMED, last updated Jun 11, 2026

B-06936155804528

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: InTec PRODUCTS, INC.

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentProfessional testingAnimal tissues / cells

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST	`ITP03004-TC40`	`06936155804528`	1	On the market