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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Total triiodothyronine (TT3) IVD, calibrator FDA UDI
Device Name
ARCHITECT Total T3 Calibrators FDA UDI
Model / Reference
7K64-01 FDA UDI
Description
ARCHITECT Total T3 Calibrators FDA UDI

Identifiers

Catalog Number
07K6401 FDA UDI
Primary DI / UDI-DI
00380740014308 FDA UDI
FDA Product Code
JIT FDA UDI
CDP FDA UDI
JJX FDA UDI
GMDN Term
Total triiodothyronine (TT3) IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1710 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 triiodothyronine (TT3) IVD, calibrator

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

Similar devices

Also classified as Total triiodothyronine (TT3) IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland

Sources (1)

  • FDA UDI fbca622c-a491-4538-926c-3f046a9abca9 36 fields · synced May 30, 2026