Identity
- Trade Name
- Accutest TSH Test FDA UDI
- Generic Name
- Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay FDA UDI
- Device Name
- TSH Test - Thyroid Stimulating Hormone testing device. FDA UDI
- Model / Reference
- MD801 FDA UDI
- Description
- TSH Test - Thyroid Stimulating Hormone testing device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924801258 FDA UDI
- 510(k) Number
- K990658 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay 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
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
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: Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay
Accutest TSH Test by Jant Pharmacal Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay.
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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
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI 11ed2f9b-1c57-4529-94ca-930990c8c786 34 fields · synced Jun 8, 2026