THE EDGE Lactate Control Solution

GUDID 04713648766554

APEX BIOTECHNOLOGY CORP.

Lactate IVD, control

• Primary Device ID: 04713648766554
• NIH Device Record Key: a33c0c8c-082d-4ed5-9e0d-5c0e820cc281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THE EDGE Lactate Control Solution
• Version Model Number: The EDGE control solution
• Company DUNS: 657608092
• Company Name: APEX BIOTECHNOLOGY CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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	04713648766554 [Primary]

FDA Product Code

• KHP: Acid, Lactic, Enzymatic Method

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: 2021-01-26
• Device Publish Date: 2021-01-18

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• 04713648766547 - THE EDGE Blood Lactate Test Strip (non-sterile): 2021-01-26 25s
• 04713648766554 - THE EDGE Lactate Control Solution: 2021-01-26
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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)