Identity
- Trade Name
- VITEK® REVEAL™ SENSOR PANEL FDA UDI
- Generic Name
- Antibacterial susceptibility testing disc IVD FDA UDI
- Device Name
- The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria FDA UDI
- Model / Reference
- VITEK® REVEAL™ SENSOR PANEL FDA UDI
- Description
- The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007326929 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™ Sensor Panel by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 02dc081c-9e6b-4543-ab84-774e5fdd93a8 35 fields · synced May 30, 2026