INSTI Test Controls HIV-1 80-1071

GUDID 06865978010710

INSTI Test Controls HIV-1

BioLytical Laboratories Inc

HIV1/HIV2 antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 06865978010710
• NIH Device Record Key: bed6ea12-51de-41fa-9d6a-7b39bbf3beeb
• Commercial Distribution Discontinuation: 2016-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INSTI Test Controls HIV-1
• Version Model Number: 80-1071
• Catalog Number: 80-1071
• Company DUNS: 201060071
• Company Name: BioLytical 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: true
• 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06865978010710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP090032

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: 2015-08-21

Devices Manufactured by BioLytical Laboratories Inc

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• 00686597010303 - INSTI HIV-1 Control Test Kit: 2020-10-08 INSTI HIV-1 Control Test Kit
• 00686597010310 - INSTI HIV-1/HIV-2 Control Test Kit: 2020-10-08 INSTI HIV-1/HIV-2 Control Test Kit
• 06865978010376 - INSTI HIV-1/HIV-2 Test Controls: 2018-07-06 INSTI HIV-1/HIV-2 Test Controls
• 06865978010710 - INSTI Test Controls HIV-1: 2018-07-06INSTI Test Controls HIV-1
• 06865978010710 - INSTI Test Controls HIV-1: 2018-07-06 INSTI Test Controls HIV-1
• 06865979010184 - INSTI HIV-1/HIV-2 Antibody Test: 2018-07-06 24 Tests with support materials
• 06865979010191 - INSTI HIV-1/HIV-2 Antibody Test: 2018-07-06 Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
• 06865979010207 - INSTI HIV-1/HIV-2 Antibody Test: 2018-07-06 24 tests without support material