Other products from "MERIDIAN BIOSCIENCE CANADA INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 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. OOI Real Time Nucleic Acid Amplification System 2 MOCK PIE
2 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. PGX,OOI Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System,Real Time Nucleic Acid Amplification System 2 Revogene® Strep A
3 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. OOI,NJR Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay Sys Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test 1 Revogene® GBS LB
4 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. OOI Real Time Nucleic Acid Amplification System 2 Revogene®
5 00628055344124 410300 410300 The Revogene® C. difficile assay performed on the Revogene instrument is a quali The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI. OZN C. Difficile Toxin Gene Amplification Assay 2 Revogene® C. difficile
Other products with the same Product Codes "PMY, OOI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04053228033936 v1 9002824 Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-D Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-Dx Operational ModuleDI Numbers:QIAstat-Dx Analytical Module DI Number: 04053228033929QIAstat-Dx Operational Module DI Number: 04053228033936 QIAstat-Dx® Analyzer 1.0 QIAGEN GMBH
2 04053228033905 V1 691221 QIAstat-Dx® Respiratory Panel QIAGEN GMBH
3 04053228010838 1 9002035 Rotor-Gene® Q MDx QIAGEN GMBH
4 04053228010746 1 9001301 QIAsymphony AS QIAGEN GMBH
5 04015630929016 05200881001 05200881001 cobas z 480 ROCHE MOLECULAR SYSTEMS, INC.
6 03661540951947 RTK403ING RTK403ING The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) base The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. HSV 1&2 ELITe MGB Assay for CE-IVD ELITECHGROUP MDX LLC
7 03661540900051 F2102-000 F2102-000 The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides dispos The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K).ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay. ELITe InGenius® Waste Box ELITECHGROUP SPA
8 03661540900044 INT032CS The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides con The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay ELITe InGenius® SP 200 Consumable Set ELITECHGROUP SPA
9 03661540900037 INT035PCR INT035PCR The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides con The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides consumables to be used in association with the ELITe InGenius® instrument (catalog number INT030-K) for Real Time PCR reactions. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® PCR Cassette is FDA cleared only for use in association with HSV1&2 ELITe MGB® Assay. ELITe InGenius® PCR cassette ELITECHGROUP SPA
10 03661540900020 INT032SP200 INT032SP200 The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performingextraction, purification, amplification and detection.ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&2 ELITe MGB® Assay. ELITe InGenius® SP 200 ELITECHGROUP SPA
11 03661540900006 INT030-K INT030-K The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that perform The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay ELITe InGenius® ELITECHGROUP SPA
12 01812125010081 CP3511 CP3511 Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software. Acuitas OPGEN, INC.
13 01812125010074 AC043 AC043 QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. Acuitas OPGEN, INC.
14 01812125010067 AC042 AC042 QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. Acuitas OPGEN, INC.
15 01812125010067 AC042 AC042 QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. Acuitas OPGEN, INC.
16 01812125010036 KT03U01-2 KT03U01-2 A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) v A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays. Acuitas OPGEN, INC.
17 01812125010005 KT03U01-1 KT03U01-1 PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box. Acuitas OPGEN, INC.
18 00884999049314 09N20-012 09N20-012 Alinity m Bottle for Ethanol Use Alinity m ABBOTT MOLECULAR INC.
19 00884999048898 09N19-012 09N19-012 Alinity m ABBOTT MOLECULAR INC.
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23 00884999047907 09N20-003 09N20-003 Alinity m Diluent Solution Kit Alinity m ABBOTT MOLECULAR INC.
24 00884999047884 09N50-001 09N50-001 Alinity m Specimen Dilution Kit I Alinity m ABBOTT MOLECULAR INC.
25 00884999047877 09N20-001 09N20-001 Alinity m Lysis Solution Alinity m ABBOTT MOLECULAR INC.
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