No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00382903406616 | 340661 | 340661 | BD® CD3 (SK7) APC | MVU | Reagents, specific, analyte | 1 | N/A |
2 | 30382903051954 | 305195 | 305195 | NEEDLE 18X1 RB | FMI | Needle, hypodermic, single lumen | N/A | |
3 | 30382903051756 | 305175 | 305175 | NEEDLE 20GA 1IN | FMI | Needle, hypodermic, single lumen | N/A | |
4 | 00382906654212 | 665421 | 665421 | Software Kit FACSDiva v9.2 IVD | OYE | Flow cytometric reagents and accessories. | 2 | FACSDiva |
5 | 00382906651273 | 665127 | 665127 | Ki-67 (B56) FITC ASR | MVU | Reagents, specific, analyte | 1 | N/A |
6 | 00382904910907 | 491090 | 491090 | BD FocalPoint Refurbished (120V) | MNM | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED | 3 | BD FocalPoint Slide Profiler Refurbished |
7 | 00382904429676 | 442967 | 442967 | BD Viper™ LT System PCR Accessory kit | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | BD Viper™ LT System PCR Accessory kit |
8 | 00382904429584 | 442958 | 442958 | BD Viper™ LT System SDA Accessory Kit | OOI | real time Nucleic acid amplification system | 2 | BD Viper™ LT System SDA Accessory Kit |
9 | 00382904428433 | 442843 | 442843 | BD Viper™ System, Remanufactured | LSL | DNA-REAGENTS, NEISSERIA | 2 | BD Viper™ System, Remanufactured |
10 | 00382904428211 | 442821 | 442821 | BD MAX™ ExK™ DNA-3 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | BD MAX™ ExK DNA-3 |
11 | 00382904428174 | 442817 | 442817 | BD MAX™ ExK™ DNA-1 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | BD MAX™ ExK DNA-1 |
12 | 00382904428051 | 442805 | 442805 | BACTEC Blood Culture Procedural Tray | MDB | SYSTEM, BLOOD CULTURING | 1 | BD BACTEC™ Blood Culture Procedural Tray |
13 | 00382904462505 | 446250 | 446250 | BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile S BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile Swab, Sample Collection Tube, Sample Collection Tube Cap | LIO | Device, specimen collection | 1 | BD Affirm™ Affirm VPIII Sample Collection Sets |
14 | 00382904061401 | 406140 | 406140 | TRAY EPID SSHP20G3.5 L/PI X3742B | CAZ | Anesthesia conduction kit | 2 | BD perisafe, BD Epilor, BD Luer-Lok |
15 | 00382904061388 | 406138 | 406138 | TRAY EPID SSHP20G3.5 LOR5 L 2T0734 | CAZ | Anesthesia conduction kit | 2 | N/A |
16 | 00382904060770 | 406077 | 406077 | TRAY EPID SSTT17G3.5 LOR5 S/L | CAZ | Anesthesia conduction kit | 2 | N/A |
17 | 00382904060565 | 406056 | 406056 | TRAY EPID SSHP18G3.5 LOR5 S/L | CAZ | Anesthesia conduction kit | 2 | N/A |
18 | 00382904060558 | 406055 | 406055 | Tray EPID SSHP18G3.5 LOR5 L | CAZ | Anesthesia conduction kit | 2 | N/A |
19 | 00382904060305 | 406030 | 406030 | TRAY EPID SSTT17G3.5 LOR5 | CAZ | Anesthesia conduction kit | 2 | N/A |
20 | 00382904060251 | 406025 | 406025 | TRAY EPID CONT TT17G3.5 C19 | CAZ | Anesthesia conduction kit | 2 | N/A |
21 | 00382906651211 | 665121 | 665121 | CD223 (T47-530) PerCP-Cy5.5 ASR | MVU | Reagents, specific, analyte | 1 | N/A |
22 | 00382906651174 | 665117 | 665117 | CD152 (BNI3) PE ASR | MVU | Reagents, specific, analyte | 1 | N/A |
23 | 00382906651167 | 665116 | 665116 | CD42b (HIP1) PE ASR | MVU | Reagents, specific, analyte | 1 | N/A |
24 | 00382906645388 | 664538 | 664538 | BD® CD22 (S-HCL-1) PE-Cy7 | MVU | Reagents, specific, analyte | 1 | N/A |
25 | 00382906645371 | 664537 | 664537 | BD Horizon™ Mouse IgG1 (X40) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
26 | 00382906645364 | 664536 | 664536 | BD Horizon™ Anti-HLA-DR (G46-6) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
27 | 00382906645357 | 664535 | 664535 | BD Horizon™ CD45 (HI30) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
28 | 00382906645340 | 664534 | 664534 | BD Horizon™ CD23 (EBVCS-5) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
29 | 00382906645333 | 664533 | 664533 | BD Horizon™ CD20 (L27) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
30 | 00382906645326 | 664532 | 664532 | BD Horizon™ CD19 (SJ25C1) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
31 | 00382906645319 | 664531 | 664531 | BD Horizon™ CD16 (3G8) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
32 | 00382906645302 | 664530 | 664530 | BD Horizon™ CD8 (SK1) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
33 | 00382906645296 | 664529 | 664529 | BD Horizon™ CD5 (L17F12) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
34 | 00382906645289 | 664528 | 664528 | BD Horizon™ CD4 (SK3) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
35 | 00382906645272 | 664527 | 664527 | BD Horizon™ CD3 (SK7) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
36 | 00382906645265 | 664526 | 664526 | BD Horizon™ Mouse IgG1 (X40) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
37 | 00382906645258 | 664525 | 664525 | BD Horizon™ CD123 (9F5) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
38 | 00382906645241 | 664524 | 664524 | BD Horizon™ CD56 (NCAM16.2) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
39 | 00382906645234 | 664523 | 664523 | BD Horizon™ CD38 (HB7) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
40 | 00382906645227 | 664522 | 664522 | BD Horizon™ CD14 (MPhiP9) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
41 | 00382906645210 | 664521 | 664521 | BD Horizon™ CD13 (L138) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
42 | 00382906645203 | 664520 | 664520 | BD Horizon™ CD10 (HI10a) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
43 | 00382906645197 | 664519 | 664519 | BD Horizon™ CD4 (SK3) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
44 | 00382906641267 | 664126 | 664126 | BD FACSCanto™ System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
45 | 00382906641243 | 664124 | 664124 | BD FACSCanto™ II System Software | OYE,GKZ | Flow cytometric reagents and accessories.,Counter, differential cell | 2 | FACSCanto |
46 | 00382906641229 | 664122 | 664122 | BD FACSCanto™ System Software | GKZ | Counter, differential cell | 2 | FACSCanto |
47 | 00382906641199 | 664119 | 664119 | BD FACSCanto™ Clinical Software v4.0.1 | GKZ | Counter, differential cell | 2 | FACSCanto |
48 | 00382906641144 | 664114 | 664114 | BD FACSCanto™ System Software | GKZ | Counter, differential cell | 2 | FACSCanto |
49 | 00382906641120 | 664112 | 664112 | BD FACSCanto™ System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
50 | 00382906641106 | 664110 | 664110 | BD FACSCanto™ II System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
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. |