Au

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name: AU FDA UDI
Generic Name: Urea IVD, kit, enzyme spectrophotometry FDA UDI
Device Name: Urea Stat/Urea Nitrogen Stat FDA UDI
Model / Reference: OSR6541 FDA UDI
Description: Urea Stat/Urea Nitrogen Stat FDA UDI

Identifiers

Primary DI / UDI-DI: 15099590050405 FDA UDI
510(k) Number: K924693 FDA UDI
FDA Product Code: CDQ FDA UDI
GMDN Term: Urea IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1770 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Urea IVD, kit, enzyme spectrophotometry

Au by Beckman Coulter, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Beckman Coulter, Inc.

Sources (1)

FDA UDI 34cb1b7c-c321-4979-ba80-a1a4e31a9867 34 fields · synced Jun 8, 2026