27 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 14, 2024
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·December 13, 2023
ARIES SARS-CoV-2 Assay
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 24, 2022
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·October 14, 2020
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·May 25, 2022
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 13, 2022
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 5, 2023