15 results
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7ms
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Sources: EU EUDAMED, US FDA
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 Kit (CDF) Model Number: 20-006-022
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 14, 2021
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 2021
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 5, 2023
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 5, 2023
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
FDA Enforcement
Class II
·Terminated·Nanosphere, Inc.·October 1, 2014
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 13, 2022
Drop Arm Versamode"
FDA Enforcement
Class II
·Terminated·Gf Health Products·April 14, 2021
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc·December 21, 2016
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014