Accustrip 10-Parameter Urine Reagent Strip 00763924870103

GUDID 10763924870100

10-Parameter Urine Reagent Strip For Use with Accustrip URS Reader Blood, Urobilinogen, Billirubin, Protein, Nitrite, Ketone, Glucose, pH, SG, Leukocytes

JANT PHARMACAL CORPORATION

Urine catalase IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10763924870100
• NIH Device Record Key: 96a68ff2-0fb2-4e65-a17e-3f04a751b86c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accustrip 10-Parameter Urine Reagent Strip
• Version Model Number: UA870
• Catalog Number: 00763924870103
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 100
• 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	00763924870103 [Unit of Use]
GS1	10763924870100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991927

FDA Product Code

• JRE: Refractometer For Clinical Use

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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