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

• 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

Devices Manufactured by MedMira Laboratories Inc

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