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Snapshot 2026-10-11 · Link to EUDAMED

OnSite® Syphilis Ab Combo Rapid Test

UDI-DI 00855402007351Basic UDI-DI 081011446R0031CD7

Class C · IVDR · CTK Biotech Inc.

Identification
Model
R0031C
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

CTK Biotech Inc.

SRN US-MF-000024900

US · Poway

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

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Canonical device page: /device/onsite-syphilis-ab-combo-rapid-test-7351 · UDI page: /udi/00855402007351

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