INSTI HIV-1/HIV-2 Antibody Test 90-1018

GUDID 06865979010184

24 Tests with support materials

BioLytical Laboratories Inc

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

• Primary Device ID: 06865979010184
• NIH Device Record Key: a1338cd0-e84b-47a4-9115-fbaa40e1cd0e
• Commercial Distribution Discontinuation: 2015-08-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INSTI HIV-1/HIV-2 Antibody Test
• Version Model Number: With Support
• Catalog Number: 90-1018
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06865979010184 [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: 2015-02-25

On-Brand Devices [INSTI HIV-1/HIV-2 Antibody Test]

• 06865979010207: 24 tests without support material
• 06865979010191: Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 an
• 06865979010184: 24 Tests with support materials
• 00686597010198: Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 an