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URiSCAN 2 GP strip

FDA UDI

Class II (US FDA UDI)

by Yd Diagnostics

Identity

Trade Name
URiSCAN 2 GP strip FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Urinalysis dip and read strips for visual. Test for Protein and Glucose in urine. FDA UDI
Model / Reference
U201 FDA UDI
Description
Urinalysis dip and read strips for visual. Test for Protein and Glucose in urine. FDA UDI

Identifiers

Primary DI / UDI-DI
08806125680033 FDA UDI
510(k) Number
K952307 FDA UDI
FDA Product Code
JIL FDA UDI
JIR FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1340 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

No

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: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

URiSCAN 2 GP strip by Yd Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K952307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Yd Diagnostics

Sources (1)

  • FDA UDI 067764c2-f624-4923-961a-d9cf229bf488 34 fields · synced Jun 6, 2026