6 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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 Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100
FDA Enforcement
Class II
·Ongoing·NeuMoDx Molecular Inc·May 4, 2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
FDA Enforcement
Class II
·Ongoing·NeuMoDx Molecular Inc·June 15, 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 individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
FDA Enforcement
Class II
·Ongoing·NeuMoDx Molecular Inc·March 16, 2022
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
FDA Enforcement
Class II
·Terminated·NeuMoDx Molecular Inc·July 7, 2021
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) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800
FDA Enforcement
Class III
·Ongoing·NeuMoDx Molecular Inc·July 12, 2023
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
FDA Enforcement
Class II
·Ongoing·NeuMoDx Molecular Inc·August 9, 2023