Identity
- Trade Name
- Streck Cell Preservative EUDAMEDFDA UDI
- Generic Name
- Lymphocyte stabilization reagent IVD FDA UDI
- Device Name
- Streck Cell Preservative EUDAMEDAn easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains two (2) 10ml vials. FDA UDI
- Model / Reference
- 213358 EUDAMEDFDA UDI
- Description
- An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains two (2) 10ml vials. FDA UDI
Identifiers
- Catalog Number
- 213358 FDA UDI
- Primary DI / UDI-DI
- 10844509000850 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445090CY93 EUDAMED
- Unit of Use DI
- 00844509000853 EUDAMED
- FDA Product Code
- LEA FDA UDI
- EMDN Code
- W01030406 LYMPHOCYTE STABILIZING MEDIA EUDAMED
- GMDN Term
- Lymphocyte stabilization reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Yes
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 — 10 Milliliter FDA UDI
Streck Cell Preservative by Streck — Class A — 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 | 08445090CY93 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 b3942c81-6cf7-49b1-b2dd-0f59a9ed3372 61 fields · synced Jul 22, 2026
- FDA UDI c844192b-80c9-402a-9f76-e9668dd28eb0 37 fields · synced May 30, 2026