Other products from "NEUMODX MOLECULAR, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10814278020274 100100 100100 NeuMoDx Cartridge PPM General purpose reagent NeuMoDxTM Cartridge
2 10814278020267 400700 400700 NeuMoDx Lysis Buffer 4 PPM General purpose reagent NeuMoDxTM Lysis Buffer 4
3 10814278020663 600100 600100 NeuMoDx Biohazard Waste Bag PPM General purpose reagent NeuMoDxTM Biohazard Waste Bag
4 10814278020212 400100 400100 NeuMoDx Wash Reagent PPM General purpose reagent NeuMoDxTM Wash Reagent
5 10814278021264 300800 300800 QJR Reagents, 2019-Novel Coronavirus Nucleic Acid NeuMoDx SARS-CoV-2 Test Strip
6 10814278020229 400200 400200 NeuMoDx Release Reagent PPM General purpose reagent NeuMoDxTM Release Reagent
7 10814278020205 310100 310100 NeuMoDx LDT Master Mix, RNA PPM General purpose reagent NeuMoDxTM LDT Master Mix, RNA
8 10814278021301 401500 401500 NeuMoDx™ Vantage Viral Lysis Buffer PPM General Purpose Reagent 1 NeuMoDx™ Vantage Viral Lysis Buffer
9 10814278020281 100200 100200 NeuMoDx Extraction Plate PPM General purpose reagent NeuMoDxTM Extraction Plate
10 10814278020236 400400 400400 NeuMoDx Lysis Buffer 1 PPM General purpose reagent NeuMoDxTM Lysis Buffer 1
11 10814278021219 401700 401700 NeuMoDx™ Lysis Buffer 6 PPM General Purpose Reagent 1 NeuMoDx™ Lysis Buffer 6
12 10814278020861 400900 400900 NeuMoDx™ Lysis Buffer 5 PPM General Purpose Reagent 1 NeuMoDx™ Lysis Buffer 5
13 10814278020304 100400 100400 NeuMoDx LDT Probe/Primer Strip PPM General purpose reagent NeuMoDxTM LDT Probe/Primer Strip
14 10814278020250 400600 400600 NeuMoDx Lysis Buffer 3 PPM General purpose reagent NeuMoDxTM Lysis Buffer 3
15 10814278020199 210100 210100 NeuMoDx LDT Master Mix, DNA PPM General purpose reagent NeuMoDxTM LDT Master Mix, DNA
16 10814278020045 200400 200400 NeuMoDx GBS Test Strip NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test NeuMoDxTM GBS Test Strip
17 10814278021257 401600 401600 NeuMoDx™ Viral Lysis Buffer PPM General Purpose Reagent 1 NeuMoDx™ Viral Lysis Buffer
18 10814278020724 500200 500200 NeuMoDx™ 96 Molecular System OOI real time Nucleic acid amplification system 2 NeuMoDx™ 96 Molecular System
19 10814278020243 400500 400500 NeuMoDx Lysis Buffer 2 PPM General purpose reagent NeuMoDxTM Lysis Buffer 2
Other products with the same Product Code "OOI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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
2 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
3 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
4 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
5 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
6 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
7 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
8 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
9 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
10 00382904439859 443985 443985 BD MAX™ Enteric Viral Panel BD MAX™ Enteric Viral Panel BECTON, DICKINSON AND COMPANY
11 00382904437121 443712 443712 BD MAX™ Vaginal Panel BD MAX™ Vaginal Panel BECTON, DICKINSON AND COMPANY
12 00382904434618 443461 443461 Kit BD Max MRSA XT BD MAX™ MRSA XT BECTON, DICKINSON AND COMPANY
13 00382904434199 443419 443419 Kit BD MAX StaphSR BD MAX™ StaphSR BECTON, DICKINSON AND COMPANY
14 00382904433802 443380 443380 BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction T BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer BD MAX™ Enteric Parasite Panel (US/CAN) GENEOHM SCIENCES CANADA INC
15 00382904433789 443378 443378 Kit BD Max Enteric Bacterial Panel USA BD MAX™ Enteric Bacterial Panel (US/CAN) GENEOHM SCIENCES CANADA INC
16 00382904429638 442963 442963 Kit BD MAX Enteric Bacterial Panel BD MAX™ Enteric Bacterial Panel BECTON, DICKINSON AND COMPANY
17 00382904429607 442960 442960 BD MAX™Enteric Parasite Panel Contains: 24 Master Mix, 24 Extraction Tubes, 24 x BD MAX™Enteric Parasite Panel Contains: 24 Master Mix, 24 Extraction Tubes, 24 x 1.5mL Sample Buffer Tubes, 25 x Septum, 24 x Strips BD MAX™ Enteric Parasite Panel BECTON, DICKINSON AND COMPANY
18 00382904429584 442958 442958 BD Viper™ LT System SDA Accessory Kit BD Viper™ LT System SDA Accessory Kit BECTON, DICKINSON AND COMPANY
19 00382904429508 442950 442950 BD Pre-Warm Heater BD Pre-Warm Heater BECTON, DICKINSON AND COMPANY
20 00382904428396 442839 442839 BD Viper™ LT System BD Viper™ LT System BECTON, DICKINSON AND COMPANY
21 00382904419271 441927 441927 Instrument Max Clinical Refurb BD MAX™ Instrument, Remanufactured BECTON, DICKINSON AND COMPANY
22 00382904419165 441916 441916 Instrument Max Clinical BD MAX™ System, BD MAX™ Instrument BECTON, DICKINSON AND COMPANY
23 00382904417727 441772 441772 Kit BD Max GBS BD MAX™ GBS BECTON, DICKINSON AND COMPANY
24 B178GBSTEC100 GBSTEC-10 GBSTEC-10 Shiga Toxin Direct Test Cartridge with sample prep device. Shiga Toxin Direct Test GREAT BASIN SCIENTIFIC, INC.
25 B178GBSIDR100 GBSIDR-10 GBSIDR-10 Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC.
26 B178GBSBPP100 GBSBPP-10 GBSBPP-10 Stool Bacterial Pathogens Panel Cartridge with sample prep device. Stool Bacterial Pathogens Panel GREAT BASIN SCIENTIFIC, INC.
27 B178GBGBS100 GBGBS-10 GBGBS-10 Group B Strep Assay GREAT BASIN SCIENTIFIC, INC.
28 B178GBBORD100 GBBORD-10 GBBORD-10 Bordetella Direct Test Cartridge Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC.
29 40816101025082 MOL1451 Direct Amplification Disc DIASORIN MOLECULAR LLC
30 40816101025075 MOL1400 Universal Disc DIASORIN MOLECULAR LLC
31 30816101025092 MOL1455 Direct Amplification Disc Kit DIASORIN MOLECULAR LLC
32 30816101025085 MOL1451 Direct Amplification Disc DIASORIN MOLECULAR LLC
33 30816101025078 MOL1401 Universal Disc DIASORIN MOLECULAR LLC
34 30382904419944 441994 441994 BD Viper™ SDA Extraction Reagent Trough BD Viper™ SDA Extraction Reagent Trough BECTON, DICKINSON AND COMPANY
35 30382904375196 437519 437519 BD PCR Cartridges 24EA BD MAX™ PCR Cartridge BECTON, DICKINSON AND COMPANY
36 30014613311058 Direct C. difficile Assay M105 Lyra Direct CDIFF Assay Lyra QUIDEL CORPORATION
37 30014613311003 M100 M100 Lyra FLU A+B Assay Lyra DIAGNOSTIC HYBRIDS, INC.
38 20816101025651 MOL3560 MOL3560 Simplexa™ GBS Positive Control Pack DIASORIN MOLECULAR LLC
39 20816101025644 MOL3550 MOL3550 Simplexa™ GBS Direct DIASORIN MOLECULAR LLC
40 16974900600091 SWSI-02 Shineway ZHUHAI SHINEWAY BIOTECH CO.,LTD
41 16974900600039 SWM-02 Shineway ZHUHAI SHINEWAY BIOTECH CO.,LTD
42 15420045506398 PROPARAFLU+ KIT, 100 REACTIONS 303677 PRODESSE HOLOGIC, INC.
43 15420045506374 PROFAST+ KIT, 100 REACTIONS 303673 PRODESSE HOLOGIC, INC.
44 10816101025111 MOL1500 Universal Disc Cover Tape DIASORIN MOLECULAR LLC
45 10816101025036 MOL1011-P Integrated Cycler (220V) Pre-Owned DIASORIN MOLECULAR LLC
46 10816101025029 MOL1011 Integrated Cycler (220V) DIASORIN MOLECULAR LLC
47 10816101025012 MOL1001-P Integrated Cyler (110V) Pre-Owned DIASORIN MOLECULAR LLC
48 10816101025005 MOL1001 Integrated Cyler (110V) DIASORIN MOLECULAR LLC
49 10814278020724 500200 500200 NeuMoDx™ 96 Molecular System NeuMoDx™ 96 Molecular System NEUMODX MOLECULAR, INC.
50 10814278020014 500100 500100 NeuMoDx™ 288 Molecular System NeuMoDx™ 288 Molecular System NEUMODX MOLECULAR, INC.