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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device real time nucleic acid amplification system
Definition The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
Product CodeOOI
Regulation Number 862.2570
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIDIAN BIOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Apr-19-2024
2 Abbott Molecular, Inc. III Feb-26-2024
3 Abbott Molecular, Inc. II Apr-06-2023
4 Abbott Molecular, Inc. II Jan-20-2023
5 Abbott Molecular, Inc. II Nov-18-2022
6 Abbott Molecular, Inc. II Mar-02-2022
7 DiaSorin Molecular LLC II Jul-18-2023
8 DiaSorin Molecular LLC II Jan-05-2022
9 Hologic, Inc. II Jan-23-2024
10 Luminex Corporation II May-13-2022
11 Luminex Corporation II Feb-02-2022
12 Luminex Corporation II Jan-14-2022
13 Luminex Corporation II Aug-19-2019
14 Luminex Corporation II Aug-15-2019
15 Meridian Bioscience Inc II Jul-28-2022
16 Meridian Bioscience Inc II Mar-30-2022
17 Qiagen Sciences LLC II Mar-12-2020
18 Roche Molecular Systems, Inc. II Mar-28-2022
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