ACCUTEST Uriscreen Rapid Screen for UTI. Test

Basic Information

• Brand Name: ACCUTEST Uriscreen Rapid Screen for UTI. Test
• Primary DI: 10763924601568
• Version / Model: ID601
• Company Name: JANT PHARMACAL CORPORATION
• Labeler DUNS: 797393659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: a5499988-f5dc-4d1e-824b-eca06371e1b8

Device Description

Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXA	Kit, Screening, Urine	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43539	Urine catalase IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10763924601568	GS1
Unit of Use	00763924601561	GS1

Premarket Submissions

Submission Number	Supplement Number
K882211	000