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 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. FDA UDI
Model / Reference: 901ab FDA UDI
Description: Validate THY 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. FDA UDI

Identifiers

Catalog Number: 901ab FDA UDI
Primary DI / UDI-DI: 00850011135723 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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.

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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 d48235a9-4c06-4b7b-9f26-1d570f8ba802 37 fields · synced Jun 9, 2026