INSTI HIV-1/HIV-2 Antibody Test

Basic Information

• Brand Name: INSTI HIV-1/HIV-2 Antibody Test
• Primary DI: 00686597010198
• Version / Model: 90-1019
• Catalog Number: 90-1019
• Company Name: Biolytical Laboratories Inc
• Labeler DUNS: 201060071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 2
• Public Version Date: 2021-11-03
• Public Version Status: Update
• Public Device Record Key: 7c572853-d799-4a25-967f-d8c7a0b170ae

Device Description

Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MZF	Test, Hiv Detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48454	HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00686597010198	GS1

Premarket Submissions

Submission Number	Supplement Number
BP090032	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius