Identity
- Trade Name
- Para 12 Plus EUDAMEDFDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- Para 12 Plus EUDAMEDA whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of normal level. FDA UDI
- Model / Reference
- 218914 EUDAMEDFDA UDI
- Description
- A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of normal level. FDA UDI
Identifiers
- Catalog Number
- 218914 FDA UDI
- Primary DI / UDI-DI
- 20844509000192 EUDAMEDFDA UDI
- Basic UDI-DI
- 0844509012+MH EUDAMED
- Unit of Use DI
- 10844509000195 EUDAMED
- 510(k) Number
- K901875 FDA UDI
- FDA Product Code
- JCN FDA UDI
- EMDN Code
- W0202010185 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES 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
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
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 — 3.0 Milliliter FDA UDI
Para 12 Plus 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 | 0844509012+MH | 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 cf36a1e9-41bf-48b5-86c2-6df7ad4ba815 61 fields · synced Jul 28, 2026
- FDA UDI 537b2a37-8bc0-4979-abc1-4f20895e14bc 38 fields · synced May 30, 2026