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PMA P160023S016

Device
Aptima HCV Quant Dx Assay
Applicant
Hologic, Inc.
PMA number
P160023
Supplement
S016
Product code
MZP
Decision date
2020-01-21
Generic name
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement
Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.

Current openFDA PMA Record#

Device
Aptima HCV Quant Dx Assay
Applicant
Hologic, Inc.
PMA number
P160023
Supplement
S016
Product code
MZP
Generic name
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date
2020-01-21
Decision code
APPR
Date received
2019-12-23
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.