INSTI HIV-1 Control Test Kit

Basic Information

• Brand Name: INSTI HIV-1 Control Test Kit
• Primary DI: 00686597010303
• Version / Model: 90-1030
• Catalog Number: 90-1030
• 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: e5ceb781-9208-45a8-b4ea-8d1c36a9ef0e

Device Description

INSTI HIV-1 Control Test Kit

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
48456	HIV1/HIV2 antibody IVD, control	A material which is used to verify the performance of an assay 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00686597010303	GS1

Premarket Submissions

Submission Number	Supplement Number
BP090032	11

Storage Conditions

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