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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
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2014
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2016
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2019
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2024
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Device
assay, enzyme linked immunosorbent, hepatitis c virus
Product Code
MZO
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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