Identity
- Trade Name
- VIDAS® FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents. FDA UDI
- Model / Reference
- 99735R FDA UDI
- Description
- The VIDAS® system is a complete standalone immunodiagnostic system using VIDAS reagents. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026152482 FDA UDI
- 510(k) Number
- K891385 FDA UDI
- FDA Product Code
- DEW FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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: Fluorescent immunoassay analyser IVD, laboratory
Vidas® by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescent immunoassay analyser IVD, laboratory.
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- Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN — Carolina Liquid Chemistries Corp. · Class I
- AutoDELFIA Sample Processor — Wallac, Inc. · Class I
- ALFIS-3 — Boditech Med, Inc.
Cleared under the same submission
K891385 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 c1bcf079-96f5-48b5-90d4-c64db71ad441 35 fields · synced Jun 8, 2026