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Cell-Free DNA BCT
EUDAMEDFDA UDIClass A (EU MDR)
Ref 230470Model Blood Collection Tube
by Streck
Identity
- Trade Name
- Cell-Free DNA BCT EUDAMEDFDA UDI
- Generic Name
- Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer FDA UDI
- Device Name
- Cell-Free DNA BCT EUDAMEDCell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next- generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device. FDA UDI
- Model / Reference
- Blood Collection Tube EUDAMED230470 EUDAMEDFDA UDI
- Description
- Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next- generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device. FDA UDI
Identifiers
- Catalog Number
- 230470 FDA UDI
- Primary DI / UDI-DI
- 20844509002257 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445090CFBCTIVDLN EUDAMED
- Direct Marketing DI
- 20844509002257 EUDAMED
- 510(k) Number
- DEN200001 FDA UDI
- FDA Product Code
- QMA FDA UDI
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
- GMDN Term
- Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1676 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Cell-Free DNA BCT by Streck — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08445090CFBCTIVDLN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Streck
- EUDAMED SRN
- US-MF-000013009
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 16f93e15-968a-4d7a-892e-e06a6b6566bc 61 fields · synced Aug 3, 2026
- FDA UDI 936b62ec-fa23-4463-8bc9-26f3e8f5b82d 36 fields · synced May 29, 2026