Identity
- Trade Name
- VITEK® REVEAL™ FDA UDI
- Generic Name
- Antimicrobial susceptibility analyser IVD FDA UDI
- Device Name
- The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details for the Reveal Instrument are provided in this manual. FDA UDI
- Model / Reference
- 900-00001 FDA UDI
- Description
- The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details for the Reveal Instrument are provided in this manual. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007326905 FDA UDI
- 510(k) Number
- K230675 FDA UDI
- FDA Product Code
- SAN FDA UDI
- GMDN Term
- Antimicrobial susceptibility analyser 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antimicrobial susceptibility analyser IVD
Vitek® Reveal™ by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antimicrobial susceptibility analyser IVD.
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- SENSITITRE VIZION — REMEL, INC. · Class II
- Selux Seaparator Reagent Kit — Selux Diagnostics, Inc. · Class II
- PBC Separator with Selux AST System — Selux Diagnostics, Inc. · Class II
- AST Inoculator — Selux Diagnostics, Inc. · Class II
- Bulk Analyzer Reagent Pack — Selux Diagnostics, Inc. · Class II
Cleared under the same submission
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 e8591995-1b67-4147-ad7c-a6c9c9204f19 34 fields · synced Jun 8, 2026