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 1 vial each of low, normal and high levels. FDA UDIA whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of low level. FDA UDI
- Model / Reference
- 218924 EUDAMEDFDA UDI218903 FDA UDI
- Description
- A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 1 vial each of low, normal and high levels. FDA UDIA whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of low level. FDA UDI
Identifiers
- Catalog Number
- 218903 FDA UDI218924 FDA UDI
- Primary DI / UDI-DI
- 00844509000211 EUDAMEDFDA UDI20844509000185 FDA UDI
- Basic UDI-DI
- 0844509012+MH EUDAMED
- Unit of Use DI
- 10844509000188 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 (3)
- EUDAMED 5d795bf1-1e8d-48a0-b793-04c07de5c652 61 fields · synced Jul 23, 2026
- FDA UDI e7c6d3fd-ac06-4cc7-9949-4f8e7a02776d 38 fields · synced May 30, 2026
- FDA UDI e282d9c4-953c-4e70-86a9-bdaf39e5bec5 38 fields · synced May 30, 2026