INSTI HIV-1/HIV-2 Control Test Kit 90-1031

GUDID 00686597010310

INSTI HIV-1/HIV-2 Control Test Kit

BioLytical Laboratories Inc

HIV1/HIV2 antibody IVD, control

• Primary Device ID: 00686597010310
• NIH Device Record Key: 334151ac-9131-4146-931a-50998255bb52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTI HIV-1/HIV-2 Control Test Kit
• Version Model Number: 90-1031
• Catalog Number: 90-1031
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686597010310 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

Devices Manufactured by BioLytical Laboratories Inc

• 00686597010198 - INSTI HIV-1/HIV-2 Antibody Test: 2020-10-08 Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
• 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: 2020-10-08INSTI HIV-1/HIV-2 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: 2018-07-06 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