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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test
Classification Namemolecular erythrocyte typing test
Generic Namemolecular erythrocyte typing test
Applicant
BioArray Solutions, Ltd.
35 technology drive suite 100
Warren , NJ 07059 
  
PMA NumberBP130026
Date Received06/11/2013
Decision Date05/21/2014
Decision Approved
Product Code
PEP[ Registered Establishments with PEP ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S004 S006 S007 S017 S018 S024 
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