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Urine Reagent Strips, 1-parameter, glucose

FDA UDI

Class II (US FDA UDI)

by Lw Scientific, Inc.

Identity

Trade Name
Urine Reagent Strips, 1-parameter, glucose FDA UDI
Generic Name
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Urine reagent strips; 1-parameter; glucose; 100 strips per vial FDA UDI
Model / Reference
URS-01PR-GL77 FDA UDI
Description
Urine reagent strips; 1-parameter; glucose; 100 strips per vial FDA UDI

Identifiers

Primary DI / UDI-DI
00664816000069 FDA UDI
510(k) Number
K942648 FDA UDI
FDA Product Code
JIL FDA UDI
GMDN Term
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1340 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

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 glucose IVD, kit, rapid colorimetric, clinical

Urine Reagent Strips, 1-parameter, glucose by Lw Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K942648 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lw Scientific, Inc.

Sources (1)

  • FDA UDI b59e7d8c-40df-4ff1-bf84-0c8445854825 35 fields · synced Jun 8, 2026