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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, calibrator FDA UDI
Device Name
ARCHITECT TSH Calibrators FDA UDI
Model / Reference
7K62-01 FDA UDI
Description
ARCHITECT TSH Calibrators FDA UDI

Identifiers

Catalog Number
07K6201 FDA UDI
Primary DI / UDI-DI
00380740014209 FDA UDI
FDA Product Code
JJX FDA UDI
JLW FDA UDI
JIT FDA UDI
GMDN Term
Thyroid stimulating hormone (TSH) IVD, calibrator 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, calibrator

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, 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 ce7e8bf6-21bf-46b4-b4d1-28e7569ca9ab 36 fields · synced May 30, 2026