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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Device INSTI? HIV-1/HIV-2 Antibody Test
Classification Namepoint of care hiv serology diagnostic and/or supplemental test
Generic Namepoint of care hiv serology diagnostic and/or supplemental test
Regulation Number866.3956
Applicant
bioLytical Laboratories, Inc
1108-13351 commerce parkway
Richmond 
british columbia CA V6V 2X7
PMA NumberBP090032
Supplement NumberS024
Date Received06/22/2020
Decision Date10/22/2020
Decision Approved
Product Code
QSU[ Registered Establishments with QSU ]
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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