Identity
- Trade Name
- Streck EUDAMEDSTaK-Chex Plus Retics FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- STaK-Chex Plus Retics - 4x4.5ml Low EUDAMEDA 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 12 vials of normal level. FDA UDI
- Model / Reference
- 225480 EUDAMED225483 EUDAMEDFDA UDI
- Description
- A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 12 vials of normal level. FDA UDI
Identifiers
- Catalog Number
- 225483 FDA UDI
- Primary DI / UDI-DI
- 30844509000335 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445090STKRQM EUDAMED
- Direct Marketing DI
- 30844509000335 EUDAMED
- 510(k) Number
- K090137 FDA UDI
- FDA Product Code
- GLQ FDA UDI
- EMDN Code
- W0103010503 MULTILEVEL 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 — 4.5 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 | 08445090STKRQM | 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 b943baac-6b7f-430c-8212-81b80e2ffc6d 61 fields · synced Jul 8, 2026
- FDA UDI 00f33b30-d0fc-497a-8e8f-30204eadfa48 38 fields · synced May 29, 2026