UASure II Uric Acid Control Solution L1 S5800397

GUDID 00886338000055

Level 1

APEX BIOTECHNOLOGY CORP.

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• Primary Device ID: 00886338000055
• NIH Device Record Key: f4f7f13a-7265-4c11-b86b-1fd4ad89dbe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UASure II Uric Acid Control Solution L1
• Version Model Number: S5800397
• Catalog Number: S5800397
• 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: false
• Device Combination Product: false
• Single Use: false
• 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	00886338000055 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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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• 00886338000062 - UASure II Blood Uric Acid Test Strips 25s: 2022-01-04 25s foil packet
• 00886338000055 - UASure II Uric Acid Control Solution L1: 2022-01-04Level 1
• 00886338000055 - UASure II Uric Acid Control Solution L1: 2022-01-04 Level 1
• 04713648766530 - THE EDGE Blood Lactate Monitoring System: 2021-01-26 KIT
• 04713648766547 - THE EDGE Blood Lactate Test Strip (non-sterile): 2021-01-26 25s
• 04713648766554 - THE EDGE Lactate Control Solution: 2021-01-26
• 04713648766493 - ApexBio SteriLance BLOOD LANCET (Sterile): 2020-05-25
• 04713648766462 - UASure Blood Uric Acid Monitoring Meter: 2020-05-19 Kit (5s)