Identity
- Trade Name
- BD BBL™ TB Fluorescent Stain Kit M FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- BD BBL™ TB Fluorescent Stain Kit M Contains: 1 each, TB Auramine M 250 mL, TB Decolorizer TM 250 mL, TB Potassium Permangante 250 mL FDA UDI
- Model / Reference
- 212519 FDA UDI
- Description
- BD BBL™ TB Fluorescent Stain Kit M Contains: 1 each, TB Auramine M 250 mL, TB Decolorizer TM 250 mL, TB Potassium Permangante 250 mL FDA UDI
Identifiers
- Catalog Number
- 212519 FDA UDI
- Primary DI / UDI-DI
- 00382902125198 FDA UDI
- FDA Product Code
- JTS FDA UDI
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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 — 250 Milliliter FDA UDI
Category: Biological stain IVD
BD BBL™ TB Fluorescent Stain Kit M by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 3934c439-7aab-48a4-9804-89b150b4d634 37 fields · synced Jun 6, 2026