Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Thyroid stimulating hormone (TSH) IVD, control FDA UDI
Device Name: ARCHITECT TSH Controls FDA UDI
Model / Reference: 7K62-10 FDA UDI
Description: ARCHITECT TSH Controls FDA UDI

Identifiers

Catalog Number: 07K6210 FDA UDI
Primary DI / UDI-DI: 00380740014216 FDA UDI
FDA Product Code: JIT FDA UDI
JJX FDA UDI
JLW FDA UDI
GMDN Term: Thyroid stimulating hormone (TSH) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
862.1660 FDA UDI
862.1690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thyroid stimulating hormone (TSH) IVD, control

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

Similar devices

Also classified as Thyroid stimulating hormone (TSH) IVD, control.

Atellica IM TSH3-UL MCM — Siemens Healthcare Diagnostics · Class I
ADVIA Centaur® TSH3-UL MCM — Siemens Healthcare Diagnostics · Class I
ADVIA Centaur® TSH MCM — Siemens Healthcare Diagnostics · Class II
TSH Control Slides — BIO SB, INC. · Class I
TSH control slides — BIO SB, INC. · Class I
IMMULITE® Systems TSH Calibration Verification Material TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
IMMULITE® Systems TSH CONTROL Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Validate — LGC Clinical Diagnostics, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Abbott Ireland

Sources (1)

FDA UDI 55141c2c-8b54-4dba-89dd-b91f8f06a5f0 36 fields · synced May 30, 2026