No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10190302004053 | 31100035 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | Medium 199, Earle's | |||
2 | 10190302003766 | 22400071 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | 1 | RPMI Medium 1640 | ||
3 | 10190302003346 | 21010046 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | Basal Medium Eagle (BME) | |||
4 | 10190302001663 | 11095072 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | 1 | MEM Earles | ||
5 | 10859952006014 | A40400 | Di Description | GGK,OZE,JJX | PRODUCTS, RED-CELL LYSING PRODUCTS,Influenza A and influenza B multiplex nucleic PRODUCTS, RED-CELL LYSING PRODUCTS,Influenza A and influenza B multiplex nucleic acid assay,Single (specified) analyte controls (assayed and unassayed) | Brand name | ||
6 | 10190302010917 | MHCD2304 | MVU | Reagents, specific, analyte | 1 | Human CD23 R-PE Conjugate | ||
7 | 10190302010894 | MHCD2205 | MVU | Reagents, specific, analyte | 1 | Human CD22 APC Conjugate | ||
8 | 10190302010863 | MHCD2201 | MVU | Reagents, specific, analyte | 1 | Human CD22 FITC Conjugate | ||
9 | 10190302009829 | MHCD0420 | MVU | Reagents, specific, analyte | 1 | Human CD4 Alexa Fluor® 488 Conjugate | ||
10 | 10190302009799 | MHCD0417 | MVU | Reagents, specific, analyte | 1 | Human CD4 PE-Texas Red® Conjugate | ||
11 | 10190302009706 | MHCD0327 | MVU | Reagents, specific, analyte | 1 | Human CD3 APC-Alexa Fluor® 750 Conj. | ||
12 | 10190302009690 | MHCD0324 | MVU | Reagents, specific, analyte | 1 | Human CD3 PE-Alexa Fluor® 700 Conj. | ||
13 | 10190302009676 | MHCD0320 | MVU | Reagents, specific, analyte | 1 | Human CD3 Alexa Fluor® 488 Conjugate | ||
14 | 10190302008617 | CD11B04 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD11b (Mac-1) R-PE Conjugate | ||
15 | 10190302008549 | CD11700 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD117 Purified Antibody | ||
16 | 10190302008488 | CD0329 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD3 Alexa Fluor® 700 Conjugate | ||
17 | 10190302008433 | CD0301 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD3 FITC Conjugate | ||
18 | 10190302008426 | CD0231 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD2 PerCP Conjugate | ||
19 | 10190302008402 | CD0217 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD2 PE-Texas Red® Conjugate | ||
20 | 10190302007221 | A26923 | MVU | Reagents, specific, analyte | 1 | MGB PROBE 100 NMOL VIC | ||
21 | 10190302005494 | MHCD1904 | GKZ | Counter, differential cell | 2 | Human CD19 R-PE Conjugate | ||
22 | 10190302017756 | A51694 | PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | 3 | Oncomine™ Dx Target Test User Guides and Assay Definition File | ||
23 | 10190302017312 | A52570, V1.1.0 | OOI | real time Nucleic acid amplification system | 2 | SAE Admin Console Dx Software V1.1.0 Kit | ||
24 | 10190302015646 | A49678 | PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | 3 | Oncomine™ Dx Target Test User Guide and Assay Definition File | ||
25 | 10190302015080 | A44551 | MVU | Reagents, specific, analyte | 1 | SMA_Si_WTProbe | ||
26 | 10190302015066 | A41856 | PCA | DNA genetic analyzer | 2 | 3500 Dx Series Data Collection Software 3 IVD Version 3.2 | ||
27 | 10190302014946 | A14326 | MVU | Reagents, specific, analyte | 1 | HSV Probe | ||
28 | 10190302014335 | A38872 | PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | 3 | Oncomine™ Dx Target RNA Control Diluent | ||
29 | 10190302012270 | MHZAP70044 | MVU | Reagents, specific, analyte | 1 | Anti-Human/Mouse ZAP-70 R-PE Conjugate | ||
30 | 10190302012171 | MHLDR04 | MVU | Reagents, specific, analyte | 1 | Anti-Human HLA-DR (Class II) R-PE Conjugate | ||
31 | 10190302012157 | MHKI6701 | MVU | Reagents, specific, analyte | 1 | Anti-Human Ki-67 FITC Conjugate | ||
32 | 10190302012140 | MHGLA044 | MVU | Reagents, specific, analyte | 1 | Anti-Human Glycophorin A (CD235a) R-PE Conjugate | ||
33 | 10190302012133 | MHGLA04 | MVU | Reagents, specific, analyte | 1 | Anti-Human Glycophorin A (CD235a) R-PE Conjugate | ||
34 | 10190302012010 | MHCD8624 | MVU | Reagents, specific, analyte | 1 | Human CD86 (B7-2/B70) PE-Alexa Fluor® 700 Conj. | ||
35 | 10190302011983 | MHCD8601 | MVU | Reagents, specific, analyte | 1 | Human CD86 (B7-2/B70) FITC Conjugate | ||
36 | 10190302011938 | MHCD8001 | MVU | Reagents, specific, analyte | 1 | Human CD80 (B7-1, BB1) FITC Conjugate | ||
37 | 10190302011921 | MHCD79B04 | MVU | Reagents, specific, analyte | 1 | Human CD79b R-PE Conjugate | ||
38 | 10190302011822 | MHCD65S01 | MVU | Reagents, specific, analyte | 1 | Human CD65s FITC Conjugate | ||
39 | 10190302011709 | MHCD5620 | MVU | Reagents, specific, analyte | 1 | Human CD56 Alexa Fluor® 488 Conjugate | ||
40 | 10190302011617 | MHCD55044 | MVU | Reagents, specific, analyte | 1 | Human CD55 R-PE Conjugate | ||
41 | 10190302011600 | MHCD5504 | MVU | Reagents, specific, analyte | 1 | Human CD55 R-PE Conjugate | ||
42 | 10190302011495 | MHCD45RA17 | MVU | Reagents, specific, analyte | 1 | Human CD45RA PE-Texas Red® Conjugate | ||
43 | 10190302011402 | MHCD4520 | MVU | Reagents, specific, analyte | 1 | Human CD45 Alexa Fluor® 488 Conjugate | ||
44 | 10190302011334 | MHCD4505 | MVU | Reagents, specific, analyte | 1 | Human CD45 APC Conjugate | ||
45 | 10190302011228 | MHCD42B04 | MVU | Reagents, specific, analyte | 1 | Human CD42b R-PE Conjugate | ||
46 | 10190302011204 | MHCD4104 | MVU | Reagents, specific, analyte | 1 | Human CD41 R-PE Conjugate | ||
47 | 10190302011143 | MHCD3817 | MVU | Reagents, specific, analyte | 1 | Human CD38 PE-Texas Red® Conjugate | ||
48 | 10190302011112 | MHCD38014 | MVU | Reagents, specific, analyte | 1 | Human CD38 FITC Conjugate | ||
49 | 10190302011105 | MHCD3801 | MVU | Reagents, specific, analyte | 1 | Human CD38 FITC Conjugate | ||
50 | 10190302011037 | MHCD2704 | MVU | Reagents, specific, analyte | 1 | Human CD27 R-PE Conjugate |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00815381020307 | RFIT-ASY-0137 | RFIT-ASY-0137 | IVD reagent kit containing 6 tests | FilmArray® Respiratory Panel 2 plus (RP2plus) | BIOFIRE DIAGNOSTICS, LLC |
2 | 00815381020291 | RFIT-ASY-0136 | RFIT-ASY-0136 | IVD reagent kit containing 30 tests | FilmArray® Respiratory Panel 2 plus (RP2plus) | BIOFIRE DIAGNOSTICS, LLC |
3 | 00815381020147 | RFIT-ASY-0120 | RFIT-ASY-0120 | IVD reagent kit containing 30 tests. | FilmArray® Respiratory Panel (RP) EZ | BIOFIRE DIAGNOSTICS, LLC |
4 | 00815381020093 | RFIT-ASY-0127 | RFIT-ASY-0127 | IVD reagent kit containing 6 tests. | FilmArray® BCID Panel | BIOFIRE DIAGNOSTICS, LLC |
5 | 00815381020086 | RFIT-ASY-0126 | RFIT-ASY-0126 | IVD reagent kit containing 30 tests. | FilmArray® BCID Panel | BIOFIRE DIAGNOSTICS, LLC |
6 | 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 |
7 | 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 |
8 | 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 |
9 | 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 |
10 | 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 |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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 |
15 | 00382904439859 | 443985 | 443985 | BD MAX™ Enteric Viral Panel | BD MAX™ Enteric Viral Panel | BECTON, DICKINSON AND COMPANY |
16 | 00382904437121 | 443712 | 443712 | BD MAX™ Vaginal Panel | BD MAX™ Vaginal Panel | BECTON, DICKINSON AND COMPANY |
17 | 00382904434618 | 443461 | 443461 | Kit BD Max MRSA XT | BD MAX™ MRSA XT | BECTON, DICKINSON AND COMPANY |
18 | 00382904434199 | 443419 | 443419 | Kit BD MAX StaphSR | BD MAX™ StaphSR | BECTON, DICKINSON AND COMPANY |
19 | 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 |
20 | 00382904433789 | 443378 | 443378 | Kit BD Max Enteric Bacterial Panel USA | BD MAX™ Enteric Bacterial Panel (US/CAN) | GENEOHM SCIENCES CANADA INC |
21 | 00382904429638 | 442963 | 442963 | Kit BD MAX Enteric Bacterial Panel | BD MAX™ Enteric Bacterial Panel | BECTON, DICKINSON AND COMPANY |
22 | 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 |
23 | 00382904429584 | 442958 | 442958 | BD Viper™ LT System SDA Accessory Kit | BD Viper™ LT System SDA Accessory Kit | BECTON, DICKINSON AND COMPANY |
24 | 00382904429508 | 442950 | 442950 | BD Pre-Warm Heater | BD Pre-Warm Heater | BECTON, DICKINSON AND COMPANY |
25 | 00382904428396 | 442839 | 442839 | BD Viper™ LT System | BD Viper™ LT System | BECTON, DICKINSON AND COMPANY |
26 | 00382904419271 | 441927 | 441927 | Instrument Max Clinical Refurb | BD MAX™ Instrument, Remanufactured | BECTON, DICKINSON AND COMPANY |
27 | 00382904419165 | 441916 | 441916 | Instrument Max Clinical | BD MAX™ System, BD MAX™ Instrument | BECTON, DICKINSON AND COMPANY |
28 | 00382904417727 | 441772 | 441772 | Kit BD Max GBS | BD MAX™ GBS | BECTON, DICKINSON AND COMPANY |
29 | B178GBSTEC100 | GBSTEC-10 | GBSTEC-10 | Shiga Toxin Direct Test Cartridge with sample prep device. | Shiga Toxin Direct Test | GREAT BASIN SCIENTIFIC, INC. |
30 | B178GBSIDR100 | GBSIDR-10 | GBSIDR-10 | Staph ID/R Blood Culture Panel | GREAT BASIN SCIENTIFIC, INC. | |
31 | B178GBSBPP100 | GBSBPP-10 | GBSBPP-10 | Stool Bacterial Pathogens Panel Cartridge with sample prep device. | Stool Bacterial Pathogens Panel | GREAT BASIN SCIENTIFIC, INC. |
32 | B178GBGBS100 | GBGBS-10 | GBGBS-10 | Group B Strep Assay | GREAT BASIN SCIENTIFIC, INC. | |
33 | B178GBBORD100 | GBBORD-10 | GBBORD-10 | Bordetella Direct Test Cartridge | Bordetella Direct Test | GREAT BASIN SCIENTIFIC, INC. |
34 | 40816101025082 | MOL1451 | Direct Amplification Disc | DIASORIN MOLECULAR LLC | ||
35 | 40816101025075 | MOL1400 | Universal Disc | DIASORIN MOLECULAR LLC | ||
36 | 30816101025092 | MOL1455 | Direct Amplification Disc Kit | DIASORIN MOLECULAR LLC | ||
37 | 30816101025085 | MOL1451 | Direct Amplification Disc | DIASORIN MOLECULAR LLC | ||
38 | 30816101025078 | MOL1401 | Universal Disc | DIASORIN MOLECULAR LLC | ||
39 | 30382904419944 | 441994 | 441994 | BD Viper™ SDA Extraction Reagent Trough | BD Viper™ SDA Extraction Reagent Trough | BECTON, DICKINSON AND COMPANY |
40 | 30382904375196 | 437519 | 437519 | BD PCR Cartridges 24EA | BD MAX™ PCR Cartridge | BECTON, DICKINSON AND COMPANY |
41 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | Lyra | QUIDEL CORPORATION |
42 | 30014613311003 | M100 | M100 | Lyra FLU A+B Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
43 | 20816101025651 | MOL3560 | MOL3560 | Simplexa™ GBS Positive Control Pack | DIASORIN MOLECULAR LLC | |
44 | 20816101025644 | MOL3550 | MOL3550 | Simplexa™ GBS Direct | DIASORIN MOLECULAR LLC | |
45 | 16974900600091 | SWSI-02 | Shineway | ZHUHAI SHINEWAY BIOTECH CO.,LTD | ||
46 | 16974900600039 | SWM-02 | Shineway | ZHUHAI SHINEWAY BIOTECH CO.,LTD | ||
47 | 15420045506398 | PROPARAFLU+ KIT, 100 REACTIONS | 303677 | PRODESSE | HOLOGIC, INC. | |
48 | 15420045506374 | PROFAST+ KIT, 100 REACTIONS | 303673 | PRODESSE | HOLOGIC, INC. | |
49 | 10816101025111 | MOL1500 | Universal Disc Cover Tape | DIASORIN MOLECULAR LLC | ||
50 | 10816101025036 | MOL1011-P | Integrated Cycler (220V) Pre-Owned | DIASORIN MOLECULAR LLC |