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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device assay, enzyme linked immunosorbent, hepatitis c virus
Product CodeMZO
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
11 12 40 24 16 10 14 19 16 17 11 13 8 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott GmbH II Apr-04-2024
2 ORTHO-CLINICAL DIAGNOSTICS II Sep-19-2014
3 OraSure Technologies, Inc. III Apr-18-2016
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