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FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name: VALIDATE FDA UDI
Generic Name: Placental growth factor (PLGF) IVD, control FDA UDI
Device Name: VALIDATE Fertility 4 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 analyte: Placental growth factor (PlGF). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 4.0 milliliters. There exists a linear relationship among Levels 1 through 5 for each set. FDA UDI
Model / Reference: 503re FDA UDI
Description: VALIDATE Fertility 4 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 analyte: Placental growth factor (PlGF). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 4.0 milliliters. There exists a linear relationship among Levels 1 through 5 for each set. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850011135679 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Placental growth factor (PLGF) 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Placental growth factor (PLGF) IVD, control

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

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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 593eff7c-c274-4d53-97fa-0a207d4ec8e9 35 fields · synced Jun 9, 2026