Nucleic acid extraction reagent (FFPE DNA)
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Nucleic acid extraction reagent (FFPE DNA) EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- N/A EUDAMEDNucleic acid extraction reagent (FFPE DNA) EUDAMED"Model: FFPE DNA-B1, Specification: 64 tests/box" FDA UDI
- Model / Reference
- N/A EUDAMEDFFPE DNA-B1、FFPE DNA-P1 EUDAMED11110 EUDAMED11111 EUDAMEDNucleic acid extraction reagent (FFPE DNA)/FFPE DNA-B1 FDA UDI
- Description
- "Model: FFPE DNA-B1, Specification: 64 tests/box" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689625035 EUDAMED06974689624076 EUDAMEDFDA UDI
- Basic UDI-DI
- 697468962503S6 EUDAMED
- FDA Product Code
- PEG FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Belgium EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid extraction/isolation kit IVD
Nucleic acid extraction reagent (FFPE DNA) by TargetingOne Technology (Beijing) Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697468962503S6 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 7168130c-af77-4f88-b6a0-656bf4b299dc 61 fields · synced Jul 22, 2026
- FDA UDI 2bfa666d-6ba4-4a6d-929b-520574cf6279 33 fields · synced May 30, 2026
- EUDAMED 87800ac9-e2c2-457f-868f-12819a2bea3b 61 fields · synced Jul 20, 2026
- EUDAMED a77d1878-a606-433a-8857-bb4267362509 61 fields · synced Jul 22, 2026