Other products from "KH MEDICAL CO., LTD."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 08800204300683 AP010 JJH Clinical Sample Concentrator 1 RADI PREP PLUS Universal DNA/RNA KIT
2 08800204300508 OP003 This product is based on magnetic extraction method that separates nucleic acids This product is based on magnetic extraction method that separates nucleic acids using a silica-coated magnetic bead. The sample is first lysed by the provided Lysis buffer to expose the nucleic acid, and the exposed nucleic acid is binds to the Silica-coated magnetic bead, and impurities are removed by the washing buffer. After this, the purified DNA/RNA is eluted with an Elution buffer. RADI 192 Viral DNA/RNA Extraction Kit
3 08800204300102 KM003 The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic ac The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biological samples including tissue, cell culture, whole blood, serum, plasma, swab, Bacteria, yeast, etc. JJH Clinical Sample Concentrator 1 RADI PREP Plus 48
4 08800204300034 OP002 This product is a nucleic acid extraction reagent capable of extracting high-pur This product is a nucleic acid extraction reagent capable of extracting high-purity DNA/RNA from plasma, saliva, feces, urine, amniotic fluid, and bone marrow of suspected virus infection patients using a Buffer Cartridge dispensed with reagents necessary for nucleic acid extraction. RADI 192 Viral DNA/RNA Extraction Kit
5 08800204300027 OE006 RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 192 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 192 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System. JJH Clinical Sample Concentrator 1 RADI Extractor 192
6 08800204300010 KM001 RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nuclei RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI PREP PLUS instrument is designed for use by laboratory professionals. 8 samples can be prepared in a single run. This Instrument is controlled through a graphical user interface.RADI PREP PLUS has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the 7 inches LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System. JJH Clinical Sample Concentrator 1 RADI PREP Plus
7 08800204300690 KM005 OOI Real Time Nucleic Acid Amplification System 2 RADI PCR 96 Plus
8 08800204300546 AP101 JJH Clinical Sample Concentrator 1 RADI PREP PLUS 48 Swab DNA,RNA Extraction Kit
9 08800204300539 AP102 JJH Clinical Sample Concentrator 1 RADI 48 Viral DNA/RNA Extraction kit
10 08800204300133 OE005 RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 32 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 32 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System. JJH Clinical Sample Concentrator 1 RADI Extractor 32
11 08800204300522 OP005 The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Ba The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Bacterial DNA and RNA from urine, stool, swab and pre-treated sputum (NaOH, NALC). Automated nucleic acid extraction can be performed with this kit by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS.The kit is intended to be use by a laboratory professional. RADI 192 Bacteria DNA/RNA Extraction Kit
12 08800204300577 AP105 JJH Clinical Sample Concentrator 1 RADI 48 Bacteria DNA Extraction Kit
13 08800204300515 OP004 The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucl The RADI 192 Tissue DNA/RNA Extraction kit is a reagent intended to extract nucleic acids from fresh or frozen tissues and cultured cells. Automated nucleic acid extraction can be performed by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS.The kit is intended to be used by a laboratory professional. RADI 192 Tissue DNA/RNA Extraction Kit
14 08800204300560 AP104 JJH Clinical Sample Concentrator 1 RADI 48 Tissue DNA Extraction Kit
15 08800204300553 AP103 JJH Clinical Sample Concentrator 1 RADI 48 Whole Blood DNA/RNA Extraction Kit
16 08800204300300 AP006 JJH Clinical Sample Concentrator 1 RADI PREP PLUS Swab and Stool DNARNA KIT
Other products with the same Product Code "OOI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00840733102370 410500 410500 The revogene Carba assay performed on the revogene instrument is a qualitative i The revogene 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 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. Revogene Carba C MERIDIAN BIOSCIENCE, INC.
2 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. Revogene GBS LB MERIDIAN BIOSCIENCE, INC.
3 00840733102332 610208 610208 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 the 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. Revogene Mock Pie MERIDIAN BIOSCIENCE, INC.
4 00840733102325 410400 The revogene Strep A assay, performed on the revogene instrument, is an automate 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. The revogene Strep A assay is intended for use as an aid in the diagnosis of the Group A Streptococcus infection.The revogene Strep A assay is intended for use in hospital, reference or state laboratory settings. Revogene Strep A MERIDIAN BIOSCIENCE, INC.
5 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. Revogene MERIDIAN BIOSCIENCE, INC.
6 00840733102264 480150 480150 The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Aleth The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. Alethia™ Group A Streptococcus MERIDIAN BIOSCIENCE, INC.
7 00840733102189 480250 480250 The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.The Alethia Mycoplasma Direct 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 Alethia Mycoplasma Direct 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. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary. Alethia™ Mycoplasma Direct MERIDIAN BIOSCIENCE, INC.
8 00840733102127 479910 479910 The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia™ Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia™ Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. Alethia™ Group A Streptococcus External Control Kit MERIDIAN BIOSCIENCE, INC.
9 00840733102103 479890 479890 The Alethia Mycoplasma Direct External Control Kit contains Positive Control Rea The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct 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. Alethia™ Mycoplasma Direct External Control Kit MERIDIAN BIOSCIENCE, INC.
10 00840733101663 610189 610189 Alethia™ is an automated isothermal amplification and detection system for use w Alethia™ is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc.’s Alethia Loop-Mediated Amplification assays. Alethia™ MERIDIAN BIOSCIENCE, INC.
11 00840733101335 280150 280150 The illumigene Group A Streptococcus (Group A Strep) assay, performed on the ill The illumigene Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens.The illumigene Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the illumigene Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. illumigene Group A Streptococcus MERIDIAN BIOSCIENCE, INC.
12 00840733101328 279910 279910 The illumigene Group A Streptococcus (Group A Strep) External Control Kit contai The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. illumigene Group A Streptococcus External Control Kit MERIDIAN BIOSCIENCE, INC.
13 00840733101281 279890 279890 The illumigene Mycoplasma Direct External Control Kit contains Positive Control The illumigene Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the illumigene Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the illumigene Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. illumigene Mycoplasma Direct External Control Kit MERIDIAN BIOSCIENCE, INC.
14 00840733101274 280250 280250 The illumigene Mycoplasma Direct DNA amplification assay, performed on the illum The illumigene Mycoplasma Direct 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 swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma Direct 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 Direct 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. illumigene Mycoplasma Direct MERIDIAN BIOSCIENCE, INC.
15 00840733101243 610172 610172 The illumipro-10 is an automated isothermal amplification and detection system f The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc. illumigene Loop-Mediated Amplification products. illumipro-10 MERIDIAN BIOSCIENCE, INC.
16 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. illumigene Mycoplasma MERIDIAN BIOSCIENCE, INC.
17 00840733101144 279940 279940 The illumigene Mycoplasma External Control Kit contains Positive and Negative Co The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program. illumigene Mycoplasma External Control Kit MERIDIAN BIOSCIENCE, INC.
18 00840487101537 ARIES M12V1 The ARIES® System is a clinical multiplex test system that automates and integra The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. ARIES® System LUMINEX CORPORATION
19 00840487101490 10-0000-07R 10-0000-07R The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) Verigene® Processor SP (Refurbished) LUMINEX CORPORATION
20 00840487101483 10-0000-07 10-0000-07 The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. Verigene® Processor SP LUMINEX CORPORATION
21 00840487101476 10-0000-02R 10-0000-02R The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) Verigene® Reader (Refurbished) LUMINEX CORPORATION
22 00840487101469 50-10041 The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) ba The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. ARIES® Group A Strep Assay LUMINEX CORPORATION
23 00840487100448 CN-SW47 The SYNCT Software is a desktop application that can be utilized by an end-user The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions. SYNCT™ Software LUMINEX CORPORATION
24 00840487100417 I051C0447 I051C0447 The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. NxTAG® Respiratory Pathogen Panel LUMINEX MOLECULAR DIAGNOSTICS, INC
25 00840487100325 10-0000-02 10-0000-02 The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. Verigene® Reader LUMINEX CORPORATION
26 00840487100080 ARIES M6V1 The ARIES® M1 System is a clinical multiplex test system that automates and inte The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. ARIES® M1 System LUMINEX CORPORATION
27 00840487100073 50-10026 The ARIES® Extraction Kit is intended to extract nucleic acid from human biologi The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM). ARIES® Extraction Kit LUMINEX CORPORATION
28 00815381020307 RFIT-ASY-0137 RFIT-ASY-0137 IVD reagent kit containing 6 tests FilmArray® Respiratory Panel 2 plus (RP2plus) BIOFIRE DIAGNOSTICS, LLC
29 00815381020291 RFIT-ASY-0136 RFIT-ASY-0136 IVD reagent kit containing 30 tests FilmArray® Respiratory Panel 2 plus (RP2plus) BIOFIRE DIAGNOSTICS, LLC
30 00815381020147 RFIT-ASY-0120 RFIT-ASY-0120 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) EZ BIOFIRE DIAGNOSTICS, LLC
31 00815381020093 RFIT-ASY-0127 RFIT-ASY-0127 IVD reagent kit containing 6 tests. FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC
32 00815381020086 RFIT-ASY-0126 RFIT-ASY-0126 IVD reagent kit containing 30 tests. FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC
33 00628055344179 410400 410400 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. Revogene® Strep A MERIDIAN BIOSCIENCE CANADA INC
34 00628055344162 410500 410500 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. Revogene® Carba C MERIDIAN BIOSCIENCE CANADA INC
35 00628055344131 610208 610208 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. MOCK PIE MERIDIAN BIOSCIENCE CANADA INC
36 00628055344117 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. Revogene® GBS LB MERIDIAN BIOSCIENCE CANADA INC
37 00628055344100 610210 610210 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. Revogene® MERIDIAN BIOSCIENCE CANADA INC
38 00628055344087 133674 133674 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. GenePOC™ Strep A GENEPOC INC
39 00628055344070 133499 133499 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. GenePOC™ Carba GENEPOC INC
40 00628055344032 132331 132331 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. MOCK PIE GENEPOC INC
41 00628055344001 130840 130840 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. revogene™ GENEPOC INC
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