Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: CARDINAL HEALTH FDA UDI
Generic Name: Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name: Urinalysis Analyzer Kit For Urine Contains: 1 - Semi-Atuo Urine Analyzer 6 - Bottles of UA10SGL Strips X1 UAREADER1 FDA UDI
Model / Reference: UAREADER1 FDA UDI
Description: Urinalysis Analyzer Kit For Urine Contains: 1 - Semi-Atuo Urine Analyzer 6 - Bottles of UA10SGL Strips X1 UAREADER1 FDA UDI

Identifiers

Catalog Number: UAREADER1 FDA UDI
Primary DI / UDI-DI: 10885380175589 FDA UDI
FDA Product Code: JJB FDA UDI
CEN FDA UDI
JIO FDA UDI
JMT FDA UDI
JRE FDA UDI
JIN FDA UDI
JMA FDA UDI
CDM FDA UDI
JIL FDA UDI
LJX FDA UDI
JIR FDA UDI
GMDN Term: Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical Urine analyser IVD, laboratory, semi-automated

Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CARDINAL HEALTH — Cardinal Health 200, LLC · 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	Class I	Pending data

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Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI fbce4e77-5f56-4e55-a34f-5de74bcabfe7 35 fields · synced Jun 8, 2026