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ACCUTEST Uriscreen Rapid Screen for UTI. Test

FDA UDI

Class I (US FDA UDI)

by Jant Pharmacal Corp.

Identity

Trade Name
ACCUTEST Uriscreen Rapid Screen for UTI. Test FDA UDI
Generic Name
Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine. FDA UDI
Model / Reference
ID601 FDA UDI
Description
Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine. FDA UDI

Identifiers

Primary DI / UDI-DI
10763924601568 FDA UDI
510(k) Number
K882211 FDA UDI
FDA Product Code
JXA FDA UDI
GMDN Term
Urine catalase IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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: Urine catalase IVD, kit, rapid colorimetric, clinical

ACCUTEST Uriscreen Rapid Screen for UTI. Test by Jant Pharmacal Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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 a5499988-f5dc-4d1e-824b-eca06371e1b8 34 fields · synced May 31, 2026