Identity
- Trade Name
- Streck EUDAMEDCyto-Chex BCT FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, K3EDTA FDA UDI
- Device Name
- Cyto-Chex BCT 6-tube pack (2.0 ml) glass EUDAMEDA direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials. FDA UDI
- Model / Reference
- 213559 EUDAMED213361 EUDAMEDFDA UDI
- Description
- A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials. FDA UDI
Identifiers
- Catalog Number
- 213361 FDA UDI
- Primary DI / UDI-DI
- 10844509000829 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445090BCTTZ EUDAMED
- Direct Marketing DI
- 10844509000829 EUDAMED
- 510(k) Number
- K080552 FDA UDI
- FDA Product Code
- GIM FDA UDI
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
- GMDN Term
- Evacuated blood collection tube IVD, K3EDTA FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 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
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
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 — 5.0 Milliliter FDA UDI
Streck 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 | 08445090BCTTZ | 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 caa38537-9869-4197-93c0-b338695f9ffa 61 fields · synced Jun 8, 2026
- FDA UDI 486c6d8b-68f5-45bb-a6de-debc661e6c4a 38 fields · synced May 30, 2026