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QMedix™

FDA UDI

Class I (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
QMedix™ FDA UDI
Generic Name
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
QMedix™ URS-1P is intended semi-quantitative and qualitative detection of protein in urine. FDA UDI
Model / Reference
DACDURS-1P(100) FDA UDI
Description
QMedix™ URS-1P is intended semi-quantitative and qualitative detection of protein in urine. FDA UDI

Identifiers

Catalog Number
URS-1P FDA UDI
Primary DI / UDI-DI
00850054026781 FDA UDI
FDA Product Code
JIR FDA UDI
GMDN Term
Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

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: Urine protein IVD, kit, rapid colorimetric, clinical

QMedix™ by Diagnostic Automation, Inc. — Class I — 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
Diagnostic Automation, Inc.

Sources (1)

  • FDA UDI 60ad5244-8a40-4c96-af74-146695d790d6 37 fields · synced May 30, 2026