MedMira Human HIV-1 Human Test Control 1009785RCP-G3

GUDID 00628451188032

The package contains replacement component for use only with Reveal G3 Rapid HIV-1 Antibody Test. Components are lot-specific.

MedMira Laboratories Inc

HIV1 antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00628451188032
• NIH Device Record Key: 95bfa45f-9188-4aa3-b8b0-6e758538932d
• Commercial Distribution Discontinuation: 2016-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MedMira Human HIV-1 Human Test Control
• Version Model Number: 1009785RCP-G3
• Catalog Number: 1009785RCP-G3
• Company DUNS: 243757049
• Company Name: MedMira Laboratories Inc
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451188032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP000023

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-31

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