Identity
- Trade Name
- CYTORICH EUDAMEDBD CytoRich™ Red Preservative FDA UDI
- Generic Name
- Cytology fixative solution IVD FDA UDI
- Device Name
- BD CytoRich™ Red Preservative EUDAMEDFDA UDI
- Model / Reference
- 491336 EUDAMEDFDA UDI
- Description
- BD CytoRich™ Red Preservative FDA UDI
Identifiers
- Catalog Number
- 491336 FDA UDI
- Primary DI / UDI-DI
- 00382904913366 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290DLFFGUMY4V EUDAMED
- FDA Product Code
- LDZ FDA UDI
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) EUDAMED
- GMDN Term
- Cytology fixative solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Cytorich by Becton Dickinson And Company — 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 | 038290DLFFGUMY4V | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED 9d047d92-8f61-40dc-984b-16ddf4b3cdcb 61 fields · synced Jun 18, 2026
- FDA UDI 54801617-d444-4e7d-a813-e359912167ce 36 fields · synced May 30, 2026