FDA.reportPublic FDA data

BIOLYTICAL LABORATORIES INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30038714073003871407BIOLYTICAL LABORATORIES INC.1N2026-01-01406 - 13251 Delf Place Richmond British Columbia CA V6V2A2

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submission
1329441348916570BP251179
1329441392915078BP090032

GUDID#

INSTI HIV Self Test - The INSTI HIV Self Test is a single use, rapid, in vitro diagnostic qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and/or Type 2 (HIV-2) in human fingerstick whole blood. This test is intended for over-the-counter (OTC) consumer use as an aid in the diagnosis of infection with HIV-1 and HIV-2. The test is intended for use as a self test by users 18 years or older. It is not intended to be used with specimens other than fingerstick whole blood.

Biolytical Laboratories Inc

2025-11-19