Identity
- Trade Name
- VIDAS® TSH FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS TSH assay is intended for the determination of human TSH concentration in human serum or plasma as an aid in the diagnosis of thyroid or pituitary disorders. FDA UDI
- Model / Reference
- 30400-01 FDA UDI
- Description
- VIDAS TSH assay is intended for the determination of human TSH concentration in human serum or plasma as an aid in the diagnosis of thyroid or pituitary disorders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026156886 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1690 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
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
Category: Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
Vidas® Tsh by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 6e64d97d-7dc7-4ff8-a17e-fbea9491013b 34 fields · synced May 30, 2026