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Urine Reagent Strips, 1-parameter, blood

FDA UDI

Class II (US FDA UDI)

by Lw Scientific, Inc.

Identity

Trade Name
Urine Reagent Strips, 1-parameter, blood FDA UDI
Generic Name
Urine blood IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Urine reagent strips; 1-parameter; blood; 100 strips per vial FDA UDI
Model / Reference
URS-01PR-BL77 FDA UDI
Description
Urine reagent strips; 1-parameter; blood; 100 strips per vial FDA UDI

Identifiers

Primary DI / UDI-DI
00664816000076 FDA UDI
510(k) Number
K023297 FDA UDI
FDA Product Code
JIO FDA UDI
GMDN Term
Urine blood IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 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 blood IVD, kit, rapid colorimetric, clinical

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

Similar devices

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

Cleared under the same submission

K023297 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 8c676b34-cd67-403d-a578-0f0b3ec240b0 35 fields · synced Jun 1, 2026