Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Gram Decolorizer FDA UDI
- Generic Name
- Gram stain IVD, reagent FDA UDI
- Device Name
- BD BBL™ Gram Stain and Reagents EUDAMEDBD BBL™ Gram Decolorizer, 3.8 L FDA UDI
- Model / Reference
- 212528 EUDAMEDFDA UDI
- Description
- BD BBL™ Gram Decolorizer, 3.8 L FDA UDI
Identifiers
- Catalog Number
- 212528 FDA UDI
- Primary DI / UDI-DI
- 00382902125280 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290DJGZNWEXC5 EUDAMED
- FDA Product Code
- JTS FDA UDI
- EMDN Code
- W0104010899 BUFFERS, STAINS - OTHER EUDAMED
- GMDN Term
- Gram stain IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 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
Dimensions & Sizes
- Size
- Total Volume — 3.8 Liter FDA UDI
Bbl 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 | 038290DJGZNWEXC5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED 6ee0b08b-be8e-4890-8616-c8ed8186fbb4 61 fields · synced Jun 9, 2026
- FDA UDI db2cbbcd-b8eb-462b-b4c4-4a530fcae3c3 37 fields · synced May 30, 2026