Identity
- Trade Name
- Streck EUDAMEDCell-Chex FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- Cell-Chex, 3 x 2.0 mL L1-UC, L1-CC, L2 EUDAMEDCell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials each of L1-UC and L2. FDA UDI
- Model / Reference
- 212431 EUDAMED212420 EUDAMEDFDA UDI
- Description
- Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials each of L1-UC and L2. FDA UDI
Identifiers
- Catalog Number
- 212420 FDA UDI
- Primary DI / UDI-DI
- 00844509000280 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445090CX8Z EUDAMED
- Direct Marketing DI
- 00844509000280 EUDAMED
- 510(k) Number
- K101335 FDA UDI
- FDA Product Code
- GLQ FDA UDI
- EMDN Code
- W0103010501 NORMAL BLOOD CONTROLS EUDAMED
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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 — 2.0 Milliliter FDA UDI
Streck by Streck — Class B — 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 | 08445090CX8Z | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 4612a79f-86af-4b7c-98d5-b54dce18592c 61 fields · synced Jul 17, 2026
- FDA UDI bbcbac57-b7bc-4f7b-99f3-e0e819bdca9a 38 fields · synced May 30, 2026