Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Thioglycollate Medium with Calcium Carbonate Marble Chip FDA UDI
- Generic Name
- Enriched broth culture medium IVD FDA UDI
- Device Name
- BD BBL™ Thioglycollate Medium with Calcium Carbonate Marble Chip EUDAMEDBD BBL™ Thioglycollate Medium with Calcium Carbonate Marble Chip, Carton of 100 size K tubes. FDA UDI
- Model / Reference
- 298518 EUDAMEDFDA UDI
- Description
- BD BBL™ Thioglycollate Medium with Calcium Carbonate Marble Chip, Carton of 100 size K tubes. FDA UDI
Identifiers
- Catalog Number
- 298518 FDA UDI
- Primary DI / UDI-DI
- 30382902985182 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290KAIOTJBY7L EUDAMED
- Unit of Use DI
- 00382902985181 EUDAMED
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) EUDAMED
- GMDN Term
- Enriched broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2300 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
Yes
EUDAMED
Microbial Substances
Yes
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 — 9 Milliliter 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 | 038290KAIOTJBY7L | 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 76aff1d4-84d8-4845-9e0f-b8ed3208d640 61 fields · synced Oct 6, 2026
- FDA UDI f3eead80-8f91-4d4e-a61b-587a44275147 37 fields · synced May 30, 2026