Identity
- Trade Name
- VIDAS® FT4 US FDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS FT4 is an automated quantitative assay for use on the VIDAS instruments for the determination of free thyroxine (FT4) in human serum or plas ma (lithium heparin). FDA UDI
- Model / Reference
- 30459-01 FDA UDI
- Description
- VIDAS FT4 is an automated quantitative assay for use on the VIDAS instruments for the determination of free thyroxine (FT4) in human serum or plas ma (lithium heparin). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026368982 FDA UDI
- FDA Product Code
- CEC FDA UDI
- GMDN Term
- Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1695 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Vidas® Ft4 Us by Biomerieux , Inc. — 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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 2c178f8d-5ca2-498b-8fdb-83efd16c02fd 35 fields · synced Jun 6, 2026