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RevoDx HIV-1 qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP201903-250Ref IP201903-25Ref IP201903-100Ref IP201903-50Ref IP201924-25
Identity
- Trade Name
- RevoDx HIV-1 qPCR Kit EUDAMED
- Device Name
- RevoDx HIV-1 qPCR Kit EUDAMED
- Model / Reference
- IP201903-250 EUDAMEDIP201903-25 EUDAMEDIP201903-100 EUDAMEDIP201903-50 EUDAMEDIP201924-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387212076 EUDAMED08684387212045 EUDAMED08684387212069 EUDAMED08684387212052 EUDAMED08684387215640 EUDAMED
- Basic UDI-DI
- B-08684387212076 EUDAMEDB-08684387212045 EUDAMEDB-08684387212069 EUDAMEDB-08684387212052 EUDAMEDB-08684387215640 EUDAMED
- EMDN Code
- W0105030107 HIV 1 - 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 HIV-1 qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08684387212076 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (5)
- EUDAMED 92113391-ff66-4bf3-9d1d-ede5f86e6b1d 61 fields · synced Oct 6, 2026
- EUDAMED 8442b352-3748-4728-ab59-4abe5ab4edbb 61 fields · synced May 18, 2026
- EUDAMED 63bb4f26-9eb6-487f-89ff-faaebc6efe29 61 fields · synced May 18, 2026
- EUDAMED f3729bc7-426d-4e71-aad7-0f6bc30323c4 61 fields · synced May 19, 2026
- EUDAMED 1c09d545-dc3b-4c81-9368-bff99055c1ff 61 fields · synced Jul 9, 2026