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RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit

EUDAMED

Class IVD General (EU MDR)

Ref IP202339-100

by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.

Identity

Trade Name
RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit EUDAMED
Device Name
RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit EUDAMED
Model / Reference
IP202339-100 EUDAMED

Identifiers

Primary DI / UDI-DI
08684387212762 EUDAMED
Basic UDI-DI
B-08684387212762 EUDAMED
EMDN Code
W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

EUDAMED SRN
TR-MF-000047330

Sources (1)

  • EUDAMED e1bf313a-149c-4cd4-b168-07d93ca5b805 61 fields · synced Oct 7, 2026