Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of QiagenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list NeuMoDx Molecular with 6 device recalls and 2 510(k) clearances. The most recent is a 510(k) clearance dated Dec 22, 2023: NeuMoDx CT/NG Assay 2.0.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 22, 2023 | NeuMoDx CT/NG Assay 2.0K230267 · QEP | 510(k) clearances |
| May 24, 2023 | NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 MoleculaClass II · Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing | Device recalls |
| May 15, 2023 | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs iClass III · Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip | Device recalls |
| May 13, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900Class II · There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-Co | Device recalls |
| Feb 18, 2022 | NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 TesClass II · Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assa | Device recalls |
| Jan 21, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in indivClass II · A risk for product contamination was identified for the affected product lot. If used, there is an increased potential f | Device recalls |
| May 4, 2021 | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100Class II · There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific as | Device recalls |
| Jun 26, 2018 | NeuMoDx GBS AssayK173725 · NJR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
