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)
Top companies in QJR
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Molecular, Inc. | 0 | 10 |
| Becton Dickinson & Co. | 0 | 4 |
| NeuMoDx Molecular Inc | 0 | 4 |
| Biomeme, Inc. | 0 | 3 |
| Meridian Bioscience Inc | 0 | 3 |
| DiaSorin Molecular LLC | 0 | 2 |
| Life Technologies Corporation | 0 | 2 |
| Luminex Corporation | 0 | 2 |
| Quidel Corporation | 0 | 2 |
| Roche Molecular Systems, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2025 | Abbott 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 |
QJR | None listed |
| May 12, 2025 | Abbott 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 |
QJR | None listed |
| Jun 5, 2024 | Becton 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 |
QJR | None listed |
| Jul 21, 2023 | Qiagen 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 |
QJR | None listed |
| Jul 5, 2023 | NeuMoDx 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 |
QJR | None listed |
| Mar 3, 2023 | DiaSorin Molecular LLC Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2 Open, Classified |
QJR | None listed |
| Jan 20, 2023 | Meridian 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 |
QJR | None listed |
| Dec 20, 2022 | Abbott Molecular, Inc. Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 Open, Classified |
QJR | None listed |
| Dec 20, 2022 | Abbott Molecular, Inc. Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 Open, Classified |
QJR | None listed |
| Nov 29, 2022 | GS 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 |
QJR | None listed |
| Oct 26, 2022 | Luminex Corporation ARIES SARS-CoV-2 Assay, REF: 50-10047 Open, Classified |
QJR | None listed |
| Aug 19, 2022 | Abbott 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 |
QJR | None listed |
| Jul 14, 2022 | Luminex Corporation ARIES SARS-CoV-2 Assay Open, Classified |
QJR | None listed |
| Apr 6, 2022 | MESA BIOTECH, INC Accula SARS-CoV-2 Test, REF: COV4100 Open, Classified |
QJR | None listed |
| Feb 18, 2022 | NeuMoDx 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 |
QJR | None listed |
| Feb 18, 2022 | DNA Genotek Inc. ORAcollect RNA: ORE-100 Open, Classified |
QJR | None listed |
| Jan 21, 2022 | NeuMoDx 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 |
QJR | None listed |
| Oct 20, 2021 | Biomeme, 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 |
QJR | None listed |
| Oct 14, 2021 | Abbott 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 |
QJR | None listed |
| Oct 14, 2021 | Abbott 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 |
QJR | None listed |
| Oct 14, 2021 | Abbott 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 |
QJR | None listed |
| Oct 14, 2021 | Abbott 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 |
QJR | None listed |
| Oct 14, 2021 | Abbott 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 |
QJR | None listed |
| Sep 23, 2021 | DiaSorin Molecular LLC SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 Open, Classified |
QJR | None listed |
| Aug 13, 2021 | Quidel 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 |
QJR | None listed |
| Jun 26, 2021 | Quidel Corporation Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent Terminated |
QJR | None listed |
| Jun 25, 2021 | OPTI Medical Systems, Inc OPTI SARS-CoV-2 RT-PCR Test, REF Numbers:
a) 99-57003
b) 99-57004 Open, Classified |
QJR | None listed |
| May 4, 2021 | NeuMoDx Molecular Inc NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 Terminated |
QJR | None listed |
| Apr 8, 2021 | Meridian 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 |
QJR | None listed |
| Apr 8, 2021 | Meridian 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 |
QJR | None listed |
| Mar 25, 2021 | Roche Molecular Systems, Inc. cobas Liat Analyzer: respiratory virus panel nucleic acid assay system
Catalog Number: 07341920190 Open, Classified |
QJR | None listed |
| Mar 25, 2021 | Roche 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 |
QJR | None listed |
| Mar 24, 2021 | Becton 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 |
QJR | None listed |
| Jan 7, 2021 | Becton 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 |
QJR | None listed |
| Jan 5, 2021 | Biomeme, 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 |
QJR | None listed |
| Dec 5, 2020 | VISBY 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 |
QJR | None listed |
| Oct 23, 2020 | Biomeme, 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 |
QJR | None listed |
| Aug 6, 2020 | Life 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 |
QJR | None listed |
| Aug 6, 2020 | Life 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 |
QJR | None listed |
| Jul 20, 2020 | Becton 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 |
QJR | None listed |
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