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NEPHROCHECK Calibration Verification

FDA UDI

Class I (US FDA UDI)

by Cliniqa Corporation

Identity

Trade Name
NEPHROCHECK Calibration Verification FDA UDI
Generic Name
Multiple acute kidney injury (AKI) marker IVD, control FDA UDI
Device Name
NEPHROCHECK® Calibration Verification For VIDAS® 3 FDA UDI
Model / Reference
83939 FDA UDI
Description
NEPHROCHECK® Calibration Verification For VIDAS® 3 FDA UDI

Identifiers

Primary DI / UDI-DI
00817238010332 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple acute kidney injury (AKI) marker IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

No

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

Yes

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, control

NEPHROCHECK Calibration Verification by Cliniqa Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple acute kidney injury (AKI) marker IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cliniqa Corporation

Sources (1)

  • FDA UDI 089aeb61-81f3-489d-83ef-9c1b90fb2211 33 fields · synced May 30, 2026