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Clinistix Kidney Health Test System

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Clinistix Kidney Health Test System FDA UDI
Generic Name
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Test Strips for the Determination of Albumin and Creatinine in Urine FDA UDI
Model / Reference
11643376 FDA UDI
Description
Test Strips for the Determination of Albumin and Creatinine in Urine FDA UDI

Identifiers

Primary DI / UDI-DI
00630414631707 FDA UDI
510(k) Number
K991315 FDA UDI
FDA Product Code
JFY FDA UDI
JIR FDA UDI
GMDN Term
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1225 FDA UDI
862.1645 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

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: Urine protein IVD, kit, rapid colorimetric, clinical

Clinistix Kidney Health Test System by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine protein IVD, kit, rapid colorimetric, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 41504e8d-5d10-4b5e-a052-74dae4519e22 35 fields · synced May 30, 2026