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NEPHROCHECK Test Kit

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
NEPHROCHECK Test Kit FDA UDI
Generic Name
Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older. FDA UDI
Model / Reference
500011 FDA UDI
Description
The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older. FDA UDI

Identifiers

Catalog Number
500011 FDA UDI
Primary DI / UDI-DI
B0745000110 FDA UDI
FDA Product Code
PIG FDA UDI
GMDN Term
Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1220 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

No

FDA UDI

Category: Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay

NEPHROCHECK Test Kit by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI cb10307f-d024-484c-b1bb-76d22049461f 34 fields · synced May 30, 2026