Validate

FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name: Validate FDA UDI
Generic Name: Cystatin C IVD, control FDA UDI
Device Name: Validate Diabetes is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. FDA UDI
Model / Reference: 204ro FDA UDI
Description: Validate Diabetes is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. FDA UDI

Identifiers

Catalog Number: 204ro FDA UDI
Primary DI / UDI-DI: 00850011135273 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Cystatin C 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: Beta-hydroxybutyrate IVD, control Insulin IVD, control Cystatin C IVD, control C-peptide 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 Fructosamine IVD, control.

POINTE SCIENTIFIC Fructosamine Control Set — POINTE SCIENTIFIC, INC. · Class II
Diazyme — Diazyme Laboratories, Inc.
CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 — Carolina Liquid Chemistries Corp. · Class II
Audit MicroControls Linearity DROP LQ Fructosamine for Roche Systems — Aalto Scientific, Ltd.
FRUC CONTROL 1 — Randox Laboratories, Ltd. · Class I
FRUC CONTROL 3 — Randox Laboratories, Ltd. · 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

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

Manufacturer

Manufacturer: LGC Clinical Diagnostics, Inc.

Sources (1)

FDA UDI c875af5d-dd94-460e-bd39-0e0366ac2502 37 fields · synced Jun 9, 2026