Validate

FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name: Validate FDA UDI
Generic Name: Total cortisol IVD, control FDA UDI
Device Name: Validate THY is intended for the determination of Calibration Verification/Linearity on automated instruments. FDA UDI
Model / Reference: 901re FDA UDI
Description: Validate THY is intended for the determination of Calibration Verification/Linearity on automated instruments. FDA UDI

Identifiers

Catalog Number: 901re FDA UDI
Primary DI / UDI-DI: 00850011135181 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Total cortisol 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

Yes

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 Free thyroxine (FT4) IVD, control Free triiodothyronine (FT3) IVD, control Total thyroxine (TT4) IVD, control

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

Similar devices

Also classified as Total cortisol IVD, control.

IMMULITE® Systems COR Calibration Verification Material Cortisol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
PreciControl Cortisol Urine — Roche Diagnostics Corp. · Class I
ADVIA Centaur® COR MCM — Siemens Healthcare Diagnostics · Class I
Atellica IM Cor MCM — Siemens Healthcare Diagnostics · Class II
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 e7b3137e-bfd5-4726-b3d1-77efe0c57465 37 fields · synced Jun 9, 2026