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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
Alinity FDA UDI
Generic Name
Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Alinity i T-Uptake Reagent Kit 200 Tests FDA UDI
Model / Reference
08P1220 FDA UDI
Description
Alinity i T-Uptake Reagent Kit 200 Tests FDA UDI

Identifiers

Catalog Number
08P1220 FDA UDI
Primary DI / UDI-DI
00380740131548 FDA UDI
FDA Product Code
KHQ FDA UDI
GMDN Term
Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1715 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: Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay

Alinity by Abbott Ireland Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland Diagnostics

Sources (1)

  • FDA UDI 327537d7-a8ce-4938-b37f-091993929217 36 fields · synced Jun 8, 2026