Identity
- Trade Name
- Streck EUDAMEDPara 12 Extend FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- Para 12 EXT - 18 x 2.5 mL (6 Low, 6 Normal, 6 High) EUDAMEDA Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials each of low, normal & high levels. FDA UDI
- Model / Reference
- 218750 EUDAMEDFDA UDI
- Description
- A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials each of low, normal & high levels. FDA UDI
Identifiers
- Catalog Number
- 218750 FDA UDI
- Primary DI / UDI-DI
- 00844509000648 EUDAMEDFDA UDI
- Basic UDI-DI
- 0844509012EXT5Y EUDAMED
- Direct Marketing DI
- 00844509000648 EUDAMED
- 510(k) Number
- K823498 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 — 2.5 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 | 0844509012EXT5Y | 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 ab487aa4-0857-4ff9-958e-1607ee686730 61 fields · synced May 30, 2026
- FDA UDI ad590e32-c098-438f-b906-2ec50c370850 38 fields · synced May 30, 2026