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Au

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
AU FDA UDI
Generic Name
Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
Bicarbonate FDA UDI
Model / Reference
OSR6137 FDA UDI
Description
Bicarbonate FDA UDI

Identifiers

Primary DI / UDI-DI
15099590010348 FDA UDI
510(k) Number
K131546 FDA UDI
FDA Product Code
KHS FDA UDI
GMDN Term
Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry

Au by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotometry.

Cleared under the same submission

K131546 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI 7a0cb848-1d7b-4195-bd12-00e1bad69b9e 34 fields · synced Jun 8, 2026