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Nucleic acid extraction reagent (cfDNA)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 11114-11116Model Model: cfDNA-B1 Specification: 1 ml×64 tests, 2 ml×64 tests, 4 ml×64 testsRef 11136Model B1、P1、P2、P3Ref 11114Ref 11105Model B1、P1Ref 11123Ref 11115Ref 11116
Identity
- Trade Name
- Nucleic acid extraction reagent (cfDNA) EUDAMEDNucleic acid extraction reagent EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- Nucleic acid extraction reagent (cfDNA) EUDAMEDNucleic acid extraction reagent EUDAMED"Model: CELL DNA-B1, Specification: 64 tests/box" FDA UDIModel: cfDNA-B1 4 ml×64 tests FDA UDI"Model: FFPE TNA-B1, Specification: 64 tests/bo" FDA UDIModel: cfDNA-B1 2 ml×64 tests, FDA UDI
- Model / Reference
- Model: cfDNA-B1 Specification: 1 ml×64 tests, 2 ml×64 tests, 4 ml×64 tests EUDAMED11114-11116 EUDAMEDB1、P1、P2、P3 EUDAMED11136 EUDAMED11114 EUDAMEDB1、P1 EUDAMED11105 EUDAMED11123 EUDAMED11115 EUDAMED11116 EUDAMEDNucleic acid extraction reagent (Cell DNA)/CELL DNA-B1 FDA UDINucleic acid extraction reagent (cfDNA)/ cfDNA-B1cfDNA-B1 FDA UDINucleic acid extraction reagent (FFPE TNA)/FFPE TNA-B1 FDA UDINucleic acid extraction reagent (cfDNA)/ cfDNA-B1 FDA UDI
- Description
- "Model: CELL DNA-B1, Specification: 64 tests/box" FDA UDIModel: cfDNA-B1 4 ml×64 tests FDA UDI"Model: FFPE TNA-B1, Specification: 64 tests/bo" FDA UDIModel: cfDNA-B1 2 ml×64 tests, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689625011 EUDAMED06974689624090 EUDAMEDFDA UDI06974689624021 EUDAMEDFDA UDI06974689624038 EUDAMEDFDA UDI06974689624014 EUDAMEDFDA UDI06974689625240 EUDAMED
- Basic UDI-DI
- 697468962501S2 EUDAMED697468962520S6 EUDAMED697468962512S7 EUDAMED
- FDA Product Code
- PEG FDA UDI
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMEDW01019099 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nucleic acid extraction reagent (cfDNA) by TargetingOne Technology (Beijing) Corporation — Class A — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697468962501S2 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697468962501S2 | 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 (11)
- EUDAMED 49e7a603-f919-4a33-a78b-b677a7e4ff1c 61 fields · synced Sep 18, 2026
- FDA UDI 0a983c28-7d17-4697-ba89-22faa051a1b3 33 fields · synced May 27, 2026
- FDA UDI ba066e5a-f920-48fb-a816-93d25ff28ad0 33 fields · synced May 30, 2026
- FDA UDI 10a399b7-0737-42af-86b0-35d998f573a1 33 fields · synced May 30, 2026
- FDA UDI 147a82a1-be06-4724-9ae2-5a8edc4b25b3 33 fields · synced May 30, 2026
- EUDAMED e5f372a5-9257-4a91-a717-b97314a1cb0b 61 fields · synced Jul 9, 2026
- EUDAMED d2672766-c64b-47f4-9b36-98245cd8f80d 61 fields · synced Jul 10, 2026
- EUDAMED be7c901a-ee93-4c20-9c47-e44bd31c67b9 61 fields · synced Jul 14, 2026
- EUDAMED d3418e11-9001-4fab-9acd-668f351ef5a3 61 fields · synced Jul 28, 2026
- EUDAMED b176de55-371c-422f-b11c-67424f36217a 61 fields · synced Jul 31, 2026
- EUDAMED acfec823-04c7-4275-ba80-68a4f9c249b5 61 fields · synced Sep 18, 2026