ClearanceBrief
Product code QJR ยท Class N

Reagents, 2019-Novel Coronavirus Nucleic Acid

0510(k)s in 12 months (0 all time)
0recalls in 12 months (40 all time)
0recalls that name a 510(k)
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Top companies in QJR

DateFirm and productCodeLinked 510(k)
May 12, 2025Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and diff
Open, Classified
QJRNone listed
May 12, 2025Abbott Molecular, Inc.
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection
Open, Classified
QJRNone listed
Jun 5, 2024Becton Dickinson & Co.
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Open, Classified
QJRNone listed
Jul 21, 2023Qiagen GmbH
QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E,
Open, Classified
QJRNone listed
Jul 5, 2023NeuMoDx Molecular Inc
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimen
Open, Classified
QJRNone listed
Mar 3, 2023DiaSorin Molecular LLC
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Open, Classified
QJRNone listed
Jan 20, 2023Meridian Bioscience Inc
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Open, Classified
QJRNone listed
Dec 20, 2022Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Open, Classified
QJRNone listed
Dec 20, 2022Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Open, Classified
QJRNone listed
Nov 29, 2022GS Biomark LLC
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
Open, Classified
QJRNone listed
Oct 26, 2022Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
Open, Classified
QJRNone listed
Aug 19, 2022Abbott Molecular, Inc.
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Open, Classified
QJRNone listed
Jul 14, 2022Luminex Corporation
ARIES SARS-CoV-2 Assay
Open, Classified
QJRNone listed
Apr 6, 2022MESA BIOTECH, INC
Accula SARS-CoV-2 Test, REF: COV4100
Open, Classified
QJRNone listed
Feb 18, 2022NeuMoDx Molecular Inc
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage T
Open, Classified
QJRNone listed
Feb 18, 2022DNA Genotek Inc.
ORAcollect RNA: ORE-100
Open, Classified
QJRNone listed
Jan 21, 2022NeuMoDx Molecular Inc
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with produ
Open, Classified
QJRNone listed
Oct 20, 2021Biomeme, Inc.
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
Terminated
QJRNone listed
Oct 14, 2021Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Terminated
QJRNone listed
Oct 14, 2021Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Terminated
QJRNone listed
Oct 14, 2021Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Terminated
QJRNone listed
Oct 14, 2021Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Terminated
QJRNone listed
Oct 14, 2021Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Terminated
QJRNone listed
Sep 23, 2021DiaSorin Molecular LLC
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Open, Classified
QJRNone listed
Aug 13, 2021Quidel Corporation
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-
Terminated
QJRNone listed
Jun 26, 2021Quidel Corporation
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Terminated
QJRNone listed
Jun 25, 2021OPTI Medical Systems, Inc
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Open, Classified
QJRNone listed
May 4, 2021NeuMoDx Molecular Inc
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Terminated
QJRNone listed
Apr 8, 2021Meridian Bioscience Inc
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Prot
Terminated
QJRNone listed
Apr 8, 2021Meridian Bioscience Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene instrument for the detection of SARS-CoV-2
Terminated
QJRNone listed
Mar 25, 2021Roche Molecular Systems, Inc.
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Open, Classified
QJRNone listed
Mar 25, 2021Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
Open, Classified
QJRNone listed
Mar 24, 2021Becton Dickinson & Co.
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
Terminated
QJRNone listed
Jan 7, 2021Becton Dickinson & Co.
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid
Terminated
QJRNone listed
Jan 5, 2021Biomeme, Inc.
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Fr
Terminated
QJRNone listed
Dec 5, 2020VISBY MEDICAL INC
visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administ
Terminated
QJRNone listed
Oct 23, 2020Biomeme, Inc.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test co
Terminated
QJRNone listed
Aug 6, 2020Life Technologies Corporation
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multipl
Terminated
QJRNone listed
Aug 6, 2020Life Technologies Corporation
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the
Terminated
QJRNone listed
Jul 20, 2020Becton Dickinson & Co.
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in
Terminated
QJRNone listed

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