Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device INSTI¿ HIV-1 Antibody Test Kit
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
Date Received06/29/2009
Decision Date11/29/2010
Decision Approved
Product Code
QSU[ Registered Establishments with QSU ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S007 S009 S011 S013 S015 S016 S017 S021 S024 
S025 S028 
-
-