Identity
- Trade Name
- BD BBL™ Sensi-Disc™ Ethambutol - 25 µg FDA UDI
- Generic Name
- Multiple antimycobacterial susceptibility testing kit IVD FDA UDI
- Device Name
- Disc Ethambutol Em-25 1 Ea FDA UDI
- Model / Reference
- 231575 FDA UDI
- Description
- Disc Ethambutol Em-25 1 Ea FDA UDI
Identifiers
- Catalog Number
- 231575 FDA UDI
- Primary DI / UDI-DI
- 00382902315759 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Multiple antimycobacterial susceptibility testing kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1620 FDA UDI
- Commercial Distribution
- Not 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
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
BD BBL™ Sensi-Disc™ Ethambutol - 25 µg by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI fc2bcc5b-17e7-42a9-991e-84de651c5ca2 37 fields · synced May 29, 2026