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Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Ireland

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT TSH Reagent Kit (100T) FDA UDI
Model / Reference
7K62-25 FDA UDI
Description
ARCHITECT TSH Reagent Kit (100T) FDA UDI

Identifiers

Catalog Number
07K6225 FDA UDI
Primary DI / UDI-DI
00380740014230 FDA UDI
FDA Product Code
JJX FDA UDI
JLW FDA UDI
JIT FDA UDI
GMDN Term
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
862.1690 FDA UDI
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

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 (TSH) IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Thyroid stimulating hormone (TSH) 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 1ae78876-5ce7-4c0a-ad1e-e8180390cf00 36 fields · synced Jun 1, 2026