ACCUTEST Uriscreen Rapid Screen for UTI. Test

GUDID 10763924601568

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

JANT PHARMACAL CORPORATION

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• Primary Device ID: 10763924601568
• NIH Device Record Key: a5499988-f5dc-4d1e-824b-eca06371e1b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUTEST Uriscreen Rapid Screen for UTI. Test
• Version Model Number: ID601
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763924601561 [Unit of Use]
GS1	10763924601568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882211

FDA Product Code

• JXA: Kit, Screening, Urine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-24

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• 10763924601568 - ACCUTEST Uriscreen Rapid Screen for UTI. Test: 2022-11-28Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.
• 10763924601568 - ACCUTEST Uriscreen Rapid Screen for UTI. Test: 2022-11-28 Rapid Screen for UTI, testing for Bacteriuria and presence of Somatic Cells in Urine.