Identity
- Trade Name
- VITEK® REVEAL™ BC GN02-AST FDA UDI
- Generic Name
- Antibacterial susceptibility testing disc IVD FDA UDI
- Device Name
- VITEK REVEAL BC GN02-AST is an antibiotic panel (20 panels/box) FDA UDI
- Model / Reference
- VITEK® REVEAL™ BC GN02-AST FDA UDI
- Description
- VITEK REVEAL BC GN02-AST is an antibiotic panel (20 panels/box) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026638887 FDA UDI
- 510(k) Number
- K230675 FDA UDI
- FDA Product Code
- SAN FDA UDI
- GMDN Term
- Antibacterial susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1650 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antibacterial susceptibility testing disc IVD
Vitek® Reveal™ Bc Gn02-Ast by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antibacterial susceptibility testing disc IVD.
- BD BBL™ Sensi-Disc™ Bacitracin 10 units — BECTON DICKINSON AND COMPANY · Class II
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- BD BBL™ Sensi-Disc™ Azithromycin 15 µg — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Sensi-Disc™ Oxacillin 1 µg — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Sensi-Disc™ Nitrofurantoin 300 µg — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Sensi-Disc™ Bacitracin 2 units — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Sensi-Disc™ Streptomycin 300 µg — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K230675 also covers:
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 4773f98a-f0d8-4be0-b9da-8d939f316da9 35 fields · synced Jun 8, 2026