Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, calibrator FDA UDI
- Device Name
- Alinity i TSH Calibrators FDA UDI
- Model / Reference
- 07P4801 FDA UDI
- Description
- Alinity i TSH Calibrators FDA UDI
Identifiers
- Catalog Number
- 07P4801 FDA UDI
- Primary DI / UDI-DI
- 00380740131128 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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, calibrator
Alinity by Abbott Ireland — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, calibrator.
- Calibrator Kit – TSH — QUALIGEN INC. · Class II
- Elecsys TSH Calset — Roche Diagnostics Corp. · Class II
- TSH CalSet — Roche Diagnostics Corp. · Class II
- ARCHITECT — ABBOTT IRELAND · Class I
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
- Abbott Ireland
Sources (1)
- FDA UDI 3f4f2559-16b7-44a1-8143-6475e97cad2a 36 fields · synced May 29, 2026