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Vidas® Nephrocheck®

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VIDAS® NEPHROCHECK® FDA UDI
Generic Name
Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay FDA UDI
Device Name
VIDAS NEPHROCHECK 60 TESTS is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the risk assessment for moderate or severe acute kidney injury FDA UDI
Model / Reference
421172-01 FDA UDI
Description
VIDAS NEPHROCHECK 60 TESTS is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the risk assessment for moderate or severe acute kidney injury FDA UDI

Identifiers

Primary DI / UDI-DI
03573026616038 FDA UDI
510(k) Number
K210793 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

No

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

Vidas® Nephrocheck® 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 8cdf19ab-9e83-49ca-8e26-cd69f9ae799c 35 fields · synced May 30, 2026