38 results
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29ms
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Sources: EU EUDAMED, US FDA
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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
REGARD Newborn Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Vitrectomy Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Stereotactic Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Vitrectomy Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·August 10, 2021
REGARD Core Biopsy Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code LRO·August 10, 2021
REGARD Ear Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OGR·August 10, 2021
REGARD Basic Cataract tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·August 10, 2021
REGARD Stereotactic Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OIP·August 10, 2021
REGARD Newborn Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·August 10, 2021
REGARD Ultrasound Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OIP·August 10, 2021
REGARD Ear Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Ultrasound Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Basic Cataract tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Core Biopsy Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. 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 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. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
FDA Enforcement
Class III
·Terminated·Nanosphere, Inc.·August 20, 2014
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007