39 results
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37ms
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Sources: EU EUDAMED, US FDA
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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
ARIES System and ARIES M1 System
FDA Enforcement
Class II
·Terminated·Luminex Corporation·May 24, 2017
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·November 21, 2018
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
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
FDA Enforcement
Class II
·Terminated·Luminex Corporation·September 5, 2018
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.
FDA Enforcement
Class III
·Terminated·Luminex Corporation·February 20, 2019
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
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
FDA Enforcement
Class II
·Terminated·Luminex Corporation·August 28, 2019