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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT Total T4 Reagent Kit (100T) FDA UDI
Model / Reference
7K66-27 FDA UDI
Description
ARCHITECT Total T4 Reagent Kit (100T) FDA UDI

Identifiers

Catalog Number
07K6627 FDA UDI
Primary DI / UDI-DI
00380740129484 FDA UDI
FDA Product Code
KLI FDA UDI
JIT FDA UDI
JJX FDA UDI
GMDN Term
Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1700 FDA UDI
862.1150 FDA UDI
862.1660 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: Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland

Sources (1)

  • FDA UDI 26d31ebb-5b07-407a-9cf0-1543e221b31a 36 fields · synced May 29, 2026