Leucoscreen Plus Test Kit

FDA UDI

by Vitrolife AB

Identity

Trade Name: Leucoscreen Plus Test Kit FDA UDI
Generic Name: White blood cell count IVD, kit, cell count FDA UDI
Device Name: Leucoscreen Plus Test Kit, 20 tests per kit FDA UDI
Model / Reference: 15447 FDA UDI
Description: Leucoscreen Plus Test Kit, 20 tests per kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00805360016988 FDA UDI
GMDN Term: White blood cell count IVD, kit, cell count FDA UDI

Classification

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: White blood cell count IVD, kit, cell count

Leucoscreen Plus Test Kit by Vitrolife AB — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CELL-DYN — Abbott Laboratories, 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	N/A	Pending data

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Manufacturer

Manufacturer: Vitrolife AB

Sources (1)

FDA UDI fa615ca3-fdce-46ff-aab3-8020573447dc 33 fields · synced May 30, 2026