INSTI Test Controls HIV-1

Basic Information

• Brand Name: INSTI Test Controls HIV-1
• Primary DI: 06865978010710
• Version / Model: 80-1071
• Catalog Number: 80-1071
• Company Name: Biolytical Laboratories Inc
• Labeler DUNS: 201060071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-21
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: bed6ea12-51de-41fa-9d6a-7b39bbf3beeb
• Distribution End Date: 2016-07-01

Device Description

INSTI Test Controls HIV-1

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
48432	HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from 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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06865978010710	GS1

Premarket Submissions

Submission Number	Supplement Number
BP090032	7

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -70 – -20 Degrees Celsius