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U.S. Department of Health and Human Services

Medical Device Recalls
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61 to 70 of 94 Results
Product: pcr
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The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based o... 2 12/01/2020 Biomeme, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi... 2 01/12/2021 Roche Molecular Systems, Inc.
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer pati... 2 01/29/2021 Qiagen Sciences LLC
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo... 3 02/01/2021 Biomeme, Inc.
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. ... 2 02/05/2021 Becton Dickinson & Co.
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancil... 2 04/07/2021 Hologic, Inc
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of ... 2 04/13/2021 Becton Dickinson & Co.
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C... 2 05/07/2021 Meridian Bioscience Inc
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 2 08/17/2021 OPTI Medical Systems, Inc
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 ... 2 09/15/2021 Quidel Corporation
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