GLP systems Track

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: GLP systems Track FDA UDI
Generic Name: Specimen processing instrument IVD FDA UDI
Device Name: GLP IN/OUT MODULE (IOM) FDA UDI
Model / Reference: 04Z9651 FDA UDI
Description: GLP IN/OUT MODULE (IOM) FDA UDI

Identifiers

Catalog Number: 04Z9651 FDA UDI
Primary DI / UDI-DI: 00380740196257 FDA UDI
FDA Product Code: JQP FDA UDI
JJE FDA UDI
GMDN Term: Specimen processing instrument IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2100 FDA UDI
862.2160 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Specimen processing instrument IVD

GLP systems Track by Abbott Laboratories, 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: Abbott Laboratories, Inc.

Sources (1)

FDA UDI 7ecbc795-dc31-4378-89d7-7601c2768629 36 fields · synced Jun 8, 2026