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DirEXT OneStep Pathogen DNA/RNA Extraction Reagent
EUDAMEDClass IVD General (EU MDR)
Ref IP202319-100Ref IP202319-50
Identity
- Trade Name
- DirEXT OneStep Pathogen DNA/RNA Extraction Reagent EUDAMED
- Device Name
- DirEXT OneStep Pathogen DNA/RNA Extraction Reagent EUDAMED
- Model / Reference
- IP202319-100 EUDAMEDIP202319-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683079717738 EUDAMED08684387210713 EUDAMED
- Basic UDI-DI
- B-08683079717738 EUDAMEDB-08684387210713 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDTürkiye 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
Category: Nucleic acid extraction/isolation kit IVD
DirEXT OneStep Pathogen DNA/RNA Extraction Reagent by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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-08683079717738 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (2)
- EUDAMED 2d93953a-113b-4350-9405-33d9c89a1720 61 fields · synced Sep 30, 2026
- EUDAMED 13ceb893-4ab2-4f86-883a-4a22fa88c2c8 61 fields · synced Jul 26, 2026