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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 LIAISON? XL MUREX Control HIV Ab/Ag HT; LIAISON? XL MUREX HIV Ab/Ag HT
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
DiaSorin, Inc.
1951 northwestern ave
Stillwater , MN 55082 -0285
  
PMA NumberBP190437
Supplement NumberS004
Date Received05/27/2021
Decision Date08/06/2021
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypeReal Time Process
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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