Targetingone
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Nucleic acid extraction reagent EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Nucleic acid extraction reagent EUDAMEDModel: Pathogens TNA-P1, Specification: 64 tests/box FDA UDI
- Model / Reference
- Pathogens TNA-B1、Pathogens TNA-P1、Pathogens TNA-P2 EUDAMED11020 EUDAMEDNucleic acid extraction reagent/ Pathogens TNA-P1 FDA UDI
- Description
- Model: Pathogens TNA-P1, Specification: 64 tests/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689624144 EUDAMEDFDA UDI
- Basic UDI-DI
- 697468962507SE 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
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
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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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 0c345531-4796-4db1-917d-4f04ffdc959b 33 fields · synced Jun 18, 2026
- EUDAMED 26d2105a-f26e-47d7-9530-9fc328b8f795 61 fields · synced Jun 18, 2026