Company ยท US
NeuMoDx Molecular Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2023. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 4 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 |
| PPM | General Purpose Reagent | 1 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 1 |
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2023 | NeuMoDx Molecular Inc NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s)
Ref: 100100 Open, Classified |
PPM | 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 |
| May 13, 2022 | NeuMoDx Molecular Inc NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 Open, Classified |
QLT | 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 |
| 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 |
| 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 |