9 results
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Sources: EU EUDAMED, US FDA
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures
FDA Enforcement
Class II
·Terminated·Opgen Inc·May 22, 2019
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
FDA Enforcement
Class II
·Terminated·Advandx Inc·October 31, 2012
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.
FDA Enforcement
Class II
·Terminated·Advandx Inc·October 31, 2012
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 21, 2018
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
FDA Enforcement
Class II
·Terminated·Paa Laboratories Inc·July 24, 2013
Metzenbaum Scissors 7 , Curved, Sterile The Metzenbaum Scissors 7 , Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
FDA Enforcement
Class II
·Terminated·Integra York PA, Inc·December 21, 2016
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
FDA Enforcement
Class II
·Terminated·Integra York PA, Inc·December 21, 2016
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Integra York PA, Inc·June 8, 2016
Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
FDA Enforcement
Class II
·Terminated·Integra York PA, Inc·September 17, 2014