Accustrip Urine Reagent Strip Reader

GUDID 10763924850508

Urine Reagent Strip Reader For Use With Accustrip URS 10 Urine Reagent Strips. *CLIA-Waived*

JANT PHARMACAL CORPORATION

Urine catalase IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10763924850508
• NIH Device Record Key: bac178ab-4ffe-45d7-9c03-71781bdbdd64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accustrip Urine Reagent Strip Reader
• Version Model Number: UA850
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	10763924850508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061742

FDA Product Code

• JIL: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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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