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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.
 
Trade NameABBOTT REAL TIME HCV
Classification Nameassay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP100017
Supplement NumberS005
Date Received03/01/2013
Decision Date09/25/2013
Product Code
MZP[ Registered Establishments with MZP ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an optional extended use feature to allow prepared amplification master mix and internal control to be used a second time within 14 days of initial use if stored at -25°c to -15°c; 2) process improvements to the liquid level sensing performed by the abbott m2000sp instrument; 3) the conversion of manual plate filling to automated plate filling; and 4) associated software revisions.
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