Validate Thy2

FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name: VALIDATE THY2 FDA UDI
Generic Name: Thyroglobulin IVD, control FDA UDI
Device Name: VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg). FDA UDI
Model / Reference: 908ro FDA UDI
Description: VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg). FDA UDI

Identifiers

Primary DI / UDI-DI: 00850011135600 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Thyroglobulin IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thyroglobulin IVD, control

Validate Thy2 by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Thyroglobulin IVD, control.

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Thyroglobulin Control Slides — BIO SB, INC. · Class I
Thyroglobulin Control Slides — BIO SB, INC. · Class I
Thyroglobulin Control Slides — BIO SB, INC. · Class I
IMMULITE® Systems TAD CONTROL Thyroid Autoantibody — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Tg II CalCheck 5 — Roche Diagnostics Corp. · 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 I	Pending data

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Manufacturer

Manufacturer: LGC Clinical Diagnostics, Inc.

Sources (1)

FDA UDI d62b627b-b81d-4b94-bb38-8928c9282456 35 fields · synced Jun 9, 2026