UASure II Blood Uric Acid Monitoring System S95046

GUDID 00886338000031

Complete Kit

APEX BIOTECHNOLOGY CORP.

Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent Uric acid IVD, reagent

• Primary Device ID: 00886338000031
• NIH Device Record Key: 5fe440e6-f316-4a53-9054-9054c3c1946d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UASure II Blood Uric Acid Monitoring System
• Version Model Number: S95046
• Catalog Number: S95046
• Company DUNS: 657608092
• Company Name: APEX BIOTECHNOLOGY CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00886338000031 [Primary]

FDA Product Code

• LFQ: Acid, Uric, Acid Reduction Of Ferric Ion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-04
• Device Publish Date: 2021-12-27

Devices Manufactured by APEX BIOTECHNOLOGY CORP.

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• 04713648766493 - ApexBio SteriLance BLOOD LANCET (Sterile): 2020-05-25
• 04713648766462 - UASure Blood Uric Acid Monitoring Meter: 2020-05-19 Kit (5s)