Positive Serum Control

FDA UDI

Class II (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name: Positive Serum Control FDA UDI
Generic Name: Platelet factor 4 IVD, control FDA UDI
Device Name: For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G) FDA UDI
Model / Reference: 403625 FDA UDI
Description: For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G) FDA UDI

Identifiers

Catalog Number: 403625 FDA UDI
Primary DI / UDI-DI: 10888234500438 FDA UDI
FDA Product Code: LCO FDA UDI
GMDN Term: Platelet factor 4 IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7695 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

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: Platelet factor 4 IVD, control

Positive Serum Control by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Platelet factor 4 IVD, control.

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Negative Serum Control — Immucor GTI Diagnostics, Inc. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Immucor GTI Diagnostics, Inc.

Sources (1)

FDA UDI 63ec7fbe-1995-4dc5-a017-18c9dcd4fbc3 36 fields · synced May 30, 2026