Identity
- Trade Name
- CLIAWAIVED INC FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Thyrochek One-Step Whole Blood Rapid TSH Assay FDA UDI
- Model / Reference
- THYROCHEK-120-A-KIT FDA UDI
- Description
- Thyrochek One-Step Whole Blood Rapid TSH Assay FDA UDI
Identifiers
- Catalog Number
- THYROCHEK-120-A-KIT FDA UDI
- Primary DI / UDI-DI
- 00816610020402 FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- 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
No
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, rapid ICT, self-testing
Cliawaived Inc by Cliawaived, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Cliawaived, Inc.
Sources (1)
- FDA UDI b70b23a1-5626-4e27-a607-5992c7e8a92e 35 fields · synced May 30, 2026