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Accustrip Urine Reagent Strip Reader

FDA UDI

Class II (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
Accustrip Urine Reagent Strip Reader FDA UDI
Generic Name
Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Urine Reagent Strip Reader For Use With Accustrip URS 10 Urine Reagent Strips. *CLIA-Waived* FDA UDI
Model / Reference
UA850 FDA UDI
Description
Urine Reagent Strip Reader For Use With Accustrip URS 10 Urine Reagent Strips. *CLIA-Waived* FDA UDI

Identifiers

Primary DI / UDI-DI
10763924850508 FDA UDI
510(k) Number
K061742 FDA UDI
FDA Product Code
JIL FDA UDI
GMDN Term
Urine catalase 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Urine catalase IVD, kit, rapid colorimetric, clinical

Accustrip Urine Reagent Strip Reader by Jant Pharmacal Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K061742 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jant Pharmacal Corp.

Sources (1)

  • FDA UDI bac178ab-4ffe-45d7-9c03-71781bdbdd64 34 fields · synced May 30, 2026