Other products from "MERIDIAN BIOSCIENCE, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00840733103322 9003-01 900312 Device for the collection, transportation, preservation and examination of stool Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites FHM Apparatus, Suturing, Stomach And Intestinal 1 Para-Pak CLEAN
2 00840733102592 800400 800400 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. LKS Device, Parasite Concentration 1 CON-Trate Bulk Tubes & Caps
3 00840733103285 610220 610220 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. OHQ Multi-Analyte Controls Unassayed 1 Revogene Check
4 00840733103216 330384 330384 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. IGG,JSM,FMH Formaldehyde (Formalin, Formol),Culture Media, Non-Propagating Transport,Contain Formaldehyde (Formalin, Formol),Culture Media, Non-Propagating Transport,Container, Specimen, Sterile 1 Para-Pak SAF / Clean / C&S
5 00840733103209 330384 330384 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. IGG,JSM,FMH Formaldehyde (Formalin, Formol),Culture Media, Non-Propagating Transport,Contain Formaldehyde (Formalin, Formol),Culture Media, Non-Propagating Transport,Container, Specimen, Sterile 1 Para-Pak SAF / Clean / C&S
6 00840733103148 381012 381012 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. LDX,IGG Fixative, Metallic Containing,Formaldehyde (Formalin, Formol) 1 Para-Pak Zn-PVA/Ultra 10% Formalin
7 00840733103100 331084 331084 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. FMH,LDX,IGG Container, Specimen, Sterile,Fixative, Metallic Containing,Formaldehyde (Formalin, Formol) 1 Para-Pak Zn-PVA / 10% Formalin / Clean
8 00840733102684 960400 960400 Components for Stool Concentration System LKS Device, Parasite Concentration 1 CON-Trate Funnels & Reagent A
9 00840733102905 990620 990620 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. HYI Iodine, Grams 1 Para-Pak C&S in Biobags
10 00840733102813 331084 331084 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. FMH,LDX,IGG Container, Specimen, Sterile,Fixative, Metallic Containing,Formaldehyde (Formalin, Formol) 1 Para-Pak Zn-PVA / 10% Formalin / Clean
11 00840733102691 900312 900312 Device for the collection, transportation, preservation and examination of stool Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites. FMH Container, Specimen, Sterile 1 Para-Pak CLEAN
12 00840733102639 973500 973500 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. LKS Device, Parasite Concentration 1 Para-Pak SpinCon (No Funnels)
13 00840733102615 301012 301012 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. LDX,IGG Fixative, Metallic Containing,Formaldehyde (Formalin, Formol) 1 Para-Pak Zn-PVA / 10% Formalin
14 00840733102363 410200 410200 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 1 Revogene GBS LB
15 00840733102226 480750 480750 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. OZZ Bordetella Pertussis Dna Assay System 2 Alethia™ Pertussis
16 00840733102141 479930 479930 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. OZZ Bordetella Pertussis Dna Assay System 2 Alethia™ Pertussis External Control Kit
17 00840733101977 751110 751110 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 GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1 FLU/RSV Positive Control
18 00840733101892 900312 900312 Device for the collection, transportation, preservation and examination of stool Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites. FMH Container, Specimen, Sterile 1 Para-Pak CLEAN
19 00840733101779 710030 710030 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. LYR Helicobacter Pylori 1 ImmunoCard H. pylori
20 00840733101755 696007 696007 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. GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33 1 PREMIER Adenoclone
21 00840733101731 606096 606096 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. LYR Helicobacter Pylori 1 PREMIER H. pylori
22 00840733101311 279900 279900 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
23 00840733101397 101009 101009 For the detection of circulating antibody to common systemic pathogens. JZQ Plates And Equipment, Radial Immunodiffusion 1 Fungal Immunodiffusion Plates - 4 Series
24 00840733101366 751630 751630 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. GMZ Antigens, All Types, Escherichia Coli 1 ImmunoCard STAT! EHEC
25 00840733101236 603096 603096 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). MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis 2 PREMIER Coccidioides
26 00840733101199 280750 280750 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. OZZ Bordetella Pertussis Dna Assay System 2 illumigene Pertussis
27 00840733101175 280550 280550 "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 2 illumigene Mycoplasma
28 00840733101113 250050 250050 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. MHI Giardia Spp. 2 MERIFLUOR Cryptosporidium/Giardia
29 00840733101090 140100 140100 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). GMD Antisera, Latex Agglutination, Cryptococcus Neoformans 2 Cryptococcal Antigen Latex Agglutination System (CALAS)
30 00840733103476 751110 751110 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. MJX Kit, Serological, Positive Control 1 RSV Positive Control
31 00840733103384 9008-01 9008-01 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. KDT Container, Specimen Mailer And Storage, Sterile 1 Para-Pak Enteric Plus
32 00840733103360 9002-03 9002-03 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. IGG Formaldehyde (Formalin, Formol) 1 Para-Pak Ultra SAF
33 00840733101748 696006 696006 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. GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33 1 PREMIER Adenoclone Type 40/41
34 00840733103162 381312 381312 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. FMH,LDX Container, Specimen, Sterile,Fixative, Metallic Containing 1 Para-Pak Ultra EcoFix/Clean
35 00840733102950 300212 300212 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. IGG,FMH Formaldehyde (Formalin, Formol),Container, Specimen, Sterile 1 Para-Pak SAF / Clean
36 00840733103094 330284 330284 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 1 Para-Pak LV-PVA / 10% Formalin / C&S
37 00840733103087 300212 300212 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. IGG,FMH Formaldehyde (Formalin, Formol),Container, Specimen, Sterile 1 Para-Pak SAF / Clean
38 00840733103070 330184 330184 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. FMH,IGG,IFQ Container, Specimen, Sterile,Formaldehyde (Formalin, Formol),Formulations, Mercu Container, Specimen, Sterile,Formaldehyde (Formalin, Formol),Formulations, Mercuric Chloride For Tissue 1 Para-Pak LV-PVA / 10% Formalin / Clean
39 00840733103049 300812 300812 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) 1 Para-Pak Modified (Cu) PVA/Formalin
40 00840733102585 801300 801300 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. HYW Stain, Trichrome, Mallory'S 1 Hemo-De
41 00840733103032 300812 300812 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) 1 Para-Pak Modified (Cu) PVA/Formalin
42 00840733102936 330184 330184 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. FMH,IGG,IFQ Container, Specimen, Sterile,Formaldehyde (Formalin, Formol),Formulations, Mercu Container, Specimen, Sterile,Formaldehyde (Formalin, Formol),Formulations, Mercuric Chloride For Tissue 1 Para-Pak LV-PVA / 10% Formalin / Clean
43 00840733102851 980212 980212 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. IGG Formaldehyde (Formalin, Formol) 1 Para-Pak Ultra SAF
44 00840733102806 330284 330284 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 1 Para-Pak LV-PVA / 10% Formalin / C&S
45 00840733102677 991320 991320 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. LDX Fixative, Metallic Containing 1 Para-Pak EcoFix in Biobags
46 00840733102455 980212 980212 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. IGG Formaldehyde (Formalin, Formol) 1 Para-Pak Ultra SAF
47 00840733102424 972500 972500 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. LKS Device, Parasite Concentration 1 SpinCon
48 00840733102318 610210 610210 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. OOI Real Time Nucleic Acid Amplification System 2 Revogene
49 00840733102196 480350 480350 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 1 Alethia™ Group B Streptococcus
50 00840733102172 480050 480050 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
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