iChem® VELOCITY™

FDA UDI

Class I (US FDA UDI)

by Beckman Coulter Ireland Inc.

Identity

Trade Name: iChem® VELOCITY™ FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: iChem VELOCITY Urine Chemistry Strips FDA UDI
Model / Reference: iChem VELOCITY Urine Chemistry Strips FDA UDI
Description: iChem VELOCITY Urine Chemistry Strips FDA UDI

Identifiers

Catalog Number: 800-7212 FDA UDI
Primary DI / UDI-DI: 10837461002628 FDA UDI
FDA Product Code: JJB FDA UDI
JIR FDA UDI
JIN FDA UDI
JMA FDA UDI
LJX FDA UDI
JRE FDA UDI
JMT FDA UDI
CEN FDA UDI
CDM FDA UDI
JIO FDA UDI
KQO FDA UDI
JIL FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1115 FDA UDI
862.1645 FDA UDI
862.1435 FDA UDI
862.1095 FDA UDI
864.7675 FDA UDI
862.2800 FDA UDI
862.1510 FDA UDI
862.1550 FDA UDI
862.1785 FDA UDI
864.6550 FDA UDI
862.2900 FDA UDI
862.1340 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

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

Yes

FDA UDI

Category: Urine analyser IVD, laboratory

iChem® VELOCITY™ by Beckman Coulter Ireland 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: Beckman Coulter Ireland Inc.

Sources (1)

FDA UDI 8e607f08-5aa4-4bbf-9545-3be63ca22c4c 34 fields · synced Jun 6, 2026