Targetingone
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Nucleic acid extraction reagent (cell DNA) EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Nucleic acid extraction reagent (cell DNA) EUDAMED
- Model / Reference
- CELL DNA-B1、CELL DNA-P1 EUDAMEDN/A EUDAMEDNucleic acid extraction reagent (Cell DNA)/ CELL DNA-P1, Specification: 64 tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689624106 EUDAMEDFDA UDI
- Basic UDI-DI
- 697468962504S8 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
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Targetingone by TargetingOne Technology (Beijing) Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
Sources (2)
- FDA UDI 6de6bee4-5576-4eb7-b263-77e91c17e767 32 fields · synced Jun 20, 2026
- EUDAMED 7b1843d3-4a45-4760-b403-5fb9d54e953d 61 fields · synced Jun 20, 2026