Device for the collection, transportation, preservation and examination of stool
Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites
The Meridian CON-Trate system is a complete system for concentrating and recover
The Meridian CON-Trate system is a complete system for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces.
The Revogene Check is a single-use, qualitative test utilizing automated real-ti
The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel.
Para-Pak systems are systems for the routine collection, transportation, preserv
Para-Pak systems are systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Para-Pak systems are systems for the routine collection, transportation, preserv
Para-Pak systems are systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Para-Pak systems provide standardized procedures for the routine collection, tra
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by those not trained in microbiological procedures and afford and excellent means of minimizing the adverse effects of delay in specimen transport.
Para-Pak systems provide standardized procedures for the routine collection, tra
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by those not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
The Para-Pak C&S (Culture and Sensitivity) provide a standardized procedure for
The Para-Pak C&S (Culture and Sensitivity) provide a standardized procedure for the routine collection, transportation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transport.
Para-Pak systems provide standardized procedures for the routine collection, tra
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by those not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
Device for the collection, transportation, preservation and examination of stool
Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites.
Para-Pak SpinCon is a unique patented system for the concentration of parasite
Para-Pak SpinCon is a unique patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens.
Para-Pak Systems provide standardized procedures for the routine collection, tra
Para-Pak Systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative
The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
NJR,OOI
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test,Real Time Nucleic Acid Amplification System
The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader,
The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
The Alethia Pertussis External Control Kit contains Positive Control Reagent for
The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
Device for the collection, transportation, preservation and examination of stool
Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites.
The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative pro
The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices.
Premier Adenoclone is an Enzyme immunoassay (EIA) for the qualitative detection
Premier Adenoclone is an Enzyme immunoassay (EIA) for the qualitative detection of human adenoviruses directly from stool specimens and confirms the presence of adenovirus in cell culture isolates from respiratory, ophthalmic or enteric specimens.
Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative de
Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative detection of IgG antibodies to Helicobacter pylori in human serum and plasma. Test results are intended to aid in the diagnosis of H. pylori infection.
The illumigene GBS External Control Kit contains Positive and Negative Control R
The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
1
illumigene Group B Streptococcus External Control Kit
ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative
ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detecti
The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detection of IgM and IgG antibodies directed against the TP and CF antigens of Coccidioides immitis in serum and cerebrospinal fluid (CSF).
The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10,
The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome.Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.
"The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-1
"The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management.
OOI,OZX
Real Time Nucleic Acid Amplification System,Mycoplasma Pneumoniae Dna Assay System
MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofl
MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and
The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).
RSV Positive Control is an external control reagent to be used with TRU RSV Test
RSV Positive Control is an external control reagent to be used with TRU RSV Test Kits as part of a routine quality control program.
The Para-Pak Enteric Plus provides a standardized procedure for the routine coll
The Para-Pak Enteric Plus provides a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transport.
The Para-Pak Ultra SAF is a convenient system for the routine collection, transp
The Para-Pak Ultra SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens.
Para-Pak systems provide standardized procedures for the routine collection, tra
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by those not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
The Para-Pak system is a convenient system for the routine collection, transport
The Para-Pak system is a convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Para-Pak systems provide standardized procedures for the routine collection, tra
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation.
IFQ,IGG,JSM
Formulations, Mercuric Chloride For Tissue,Formaldehyde (Formalin, Formol),Cultu
Formulations, Mercuric Chloride For Tissue,Formaldehyde (Formalin, Formol),Culture Media, Non-Propagating Transport
The Para-Pak system is a convenient system for the routine collection, transport
The Para-Pak system is a convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
The Para-Pak Systems provide standardized procedures for the routine collection,
The Para-Pak Systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
Para-Pak PVA based systems provide standardized procedures for the routine colle
Para-Pak PVA based systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation.
IFQ,IGG
Formulations, Mercuric Chloride For Tissue,Formaldehyde (Formalin, Formol)
Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain
Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Ethyl acetate replacement in concentration procedures, Bulk reagent used in EcoStain kit.
Para-Pak PVA based systems provide standardized procedures for the routine colle
Para-Pak PVA based systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation.
IFQ,IGG
Formulations, Mercuric Chloride For Tissue,Formaldehyde (Formalin, Formol)
The Para-Pak Systems provide standardized procedures for the routine collection,
The Para-Pak Systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
The Para-Pak Ultra SAF is a convenient system for the routine collection, transp
The Para-Pak Ultra SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Para-Pak systems provide standardized procedures for the routine collection, tra
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation
IFQ,IGG,JSM
Formulations, Mercuric Chloride For Tissue,Formaldehyde (Formalin, Formol),Cultu
Formulations, Mercuric Chloride For Tissue,Formaldehyde (Formalin, Formol),Culture Media, Non-Propagating Transport
The Para-Pak EcoFix is a convenient, one-vial system for the routine collection,
The Para-Pak EcoFix is a convenient, one-vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from the EcoFix preserved specimen. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport.
The Para-Pak Ultra SAF is a convenient system for the routine collection, transp
The Para-Pak Ultra SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Para-Pak SpinCon is a unique, patented system for the concentration of parasite
Para-Pak SpinCon is a unique, patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF) and EcoFix may be used with this system.
The system is a clinical multiplex instrument intended to measure and sort multi
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubato
The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
The Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Ins
The Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The Alethia™ C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The Alethia™ C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.
OMN
C. Difficile Nucleic Acid Amplification Test Assay
1
Alethia™ C. difficile
Other products with the same Product Codes"OOI, OYZ"
The Revogene® Strep A assay, performed on the Revogene® instrument, is an automa
The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The Revogene Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.
The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualita
The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms.The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.
The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogen
The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run.
The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative
The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in perfor
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR.
The GenePOC Strep A assay, performed on the revogene instrument, is an automated
The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.
The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitativ
The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.
The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogen
The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run.
The revogene™ instrument is intended for in vitro diagnostic (IVD) use in perfor
The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.