No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850009370181 | 03-3140-01 | 03-3140-01 | CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system | ODV,ODW | Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system,Cytoc Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system,Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system | 2 | INFINITI® Warfarin Amplification Mix |
2 | 00850009370167 | 03-1140-01 | 03-1140-01 | CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system | ODW,ODV | Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system,Vita Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system,Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system | 2 | INFINITI® Warfarin BioFilmChip® Microarray Magazine |
3 | 00850009370136 | 03-1220-01 | 03-1220-01 | CYP2C19 drug metabolyzing enzyme genotyping system | NSU,NTI | Instrumentation for clinical multiplex test systems,Drug metabolizing enzyme gen Instrumentation for clinical multiplex test systems,Drug metabolizing enzyme genotyping systems | 2 | INFINITI® CYP2C19 BioFilmChip® Microarray Magazine |
4 | 00850009370105 | 01-1050-01 | 01-1050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | NPQ,NSU,NPR | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical mu TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical multiplex test systems,TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | 2 | INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine |
5 | 00850009370143 | 03-2220-01 | 03-2220-01 | CYP2C19 drug metabolyzing enzyme genotyping system | NTI,NSU | Drug metabolizing enzyme genotyping systems,Instrumentation for clinical multipl Drug metabolizing enzyme genotyping systems,Instrumentation for clinical multiplex test systems | 2 | INFINITI® CYP2C19 Intellipac® Reagent Module |
6 | 00850009370006 | 10-0020-99 | 10-0020-99 | Instrumentation For Clinical Multiplex Test Systems | NSU | Instrumentation for clinical multiplex test systems | 2 | INFINITI® PLUS ANALYZER |
7 | 00850009370112 | 01-2050-01 | 01-2050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | NPQ,NPR,NSU | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR II G20210A MUTATIO TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical multiplex test systems | 2 | INFINITI® Factor II-V Leiden Intellipac® Reagent Module |
8 | 00850009370020 | 10-0060-99 | 10-0060-99 | Instrumentation For Clinical Multiplex Test Systems | NSU | Instrumentation for clinical multiplex test systems | 2 | INFINITI® High Throughput System (HTS) PROCESSOR |
9 | 00850009370129 | 01-3050-01 | 01-3050-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A and Facto Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations | NSU,NPQ,NPR | Instrumentation for clinical multiplex test systems,TEST, FACTOR V LEIDEN MUTATI Instrumentation for clinical multiplex test systems,TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | 2 | INFINITI® Factor II-V Leiden Amplification Mix |
10 | 00850009370068 | 01-3020-01 | 01-3020-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. | NPR,NSU | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical multiplex test systems | 2 | INFINITI® Factor II Amplification Mix |
11 | 00850009370099 | 01-3030-01 | 01-3030-01 | Genotyping systme for the detection of the Factor V Leiden G1691A mutation | NSU,NPQ | Instrumentation for clinical multiplex test systems,TEST, FACTOR V LEIDEN MUTATI Instrumentation for clinical multiplex test systems,TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR | 2 | INFINITI® Factor V Leiden Amplification Mix |
12 | 00850009370075 | 01-1030-01 | 01-1030-01 | Genotyping system for the detection of the Factor V Leiden G1691A mutation | NPQ,NSU | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical mu TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical multiplex test systems | 2 | INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine |
13 | 00850009370044 | 01-1020-01 | 01-1020-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. | NPR,NSU | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical multiplex test systems | 2 | INFINITI® Factor II BioFilmChip® Microarray Magazine |
14 | 00850009370174 | 03-2140-01 | 03-2140-01 | CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system | ODW,ODV | Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system,Vita Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system,Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system | 2 | INFINITI® Warfarin Intellipac® Reagent Module |
15 | 00850009370150 | 03-3220-01 | 03-3220-01 | CYP2C19 drug metabolyzing enzyme genotyping system | NTI,NSU | Drug metabolizing enzyme genotyping systems,Instrumentation for clinical multipl Drug metabolizing enzyme genotyping systems,Instrumentation for clinical multiplex test systems | 2 | INFINITI® CYP2C19 Amplification Mix |
16 | 00850009370082 | 01-2030-01 | 01-2030-01 | Genotyping system for the detection of the Factor V Leiden G1691A mutation | NPQ,NSU | TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical mu TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,Instrumentation for clinical multiplex test systems | 2 | INFINITI® Factor V Leiden Intellipac® Reagent Module |
17 | 00850009370037 | 10-0070-99 | 10-0070-99 | Instrumentation For Clinical Multiplex Test Systems | NSU | Instrumentation for clinical multiplex test systems | 2 | INFINITI® High Throughput System (HTS) INCUBATOR |
18 | 00850009370013 | 10-0030-99 | 10-0030-99 | Instrumentation For Clinical Multiplex Test Systems | NSU | Instrumentation for clinical multiplex test systems | 2 | INFINITI® High Throughput System (HTS) ACE ANALYZER |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B769ICRADAA00000 | iCR-ADAA00000 | The iC-System is an in vitro diagnostic device designed to perform multiplex amp The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets. | iC-Reader | ICUBATE, INC | |
2 | B769ICPADAAA0000 | iCP-ADAAA0000 | The iC-System is an in vitro diagnostic device designed to perform multiplex amp The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets. | iC-Processor | ICUBATE, INC | |
3 | B550ENT0100 | Quality Control Tray | ENT010 | Metal tray used for quality control of OpsisDx heater | OpsisDx | ENTOPSIS, LLC |
4 | B550ENT0070 | Testing Tray | ENT007 | Metal tray used to heat OpsisDx NuTec Slides | OpsisDx | ENTOPSIS, LLC |
5 | B550ENT0040 | Standard Media | ENT004 | Media used for quality control of the OpsisDx platform | OpsisDx | ENTOPSIS, LLC |
6 | B550ENT0020 | Signal Enhancer | ENT002 | Additive used in preparing OpsisDx urine fixative and OpsisDx standard media | OpsisDx | ENTOPSIS, LLC |
7 | B550ENT0010 | NuTec Chamber | ENT001 | Four NuTec slides used to create bio-molecular profiles of samples | OpsisDx | ENTOPSIS, LLC |
8 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
9 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
10 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
11 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |
12 | B178PA5000 | PA500 | PA500 | PA500 Portrait Analyzer | GREAT BASIN SCIENTIFIC, INC. | |
13 | 30014613202783 | 20278 | 20278 | Solana instrument | Solana | QUIDEL CORPORATION |
14 | 15420045512092 | CV/TV CONTROLS, APTIMA, 100T, IVD | PRD-05190 | APTIMA | HOLOGIC, INC. | |
15 | 15420045512085 | CV/TV CALIBRATOR, APTIMA, 100T, IVD | PRD-05191 | APTIMA | HOLOGIC, INC. | |
16 | 15420045512078 | CV/TV ASSAY, APTIMA, 100T, IVD | PRD-05189 | APTIMA | HOLOGIC, INC. | |
17 | 15420045512061 | CV/TV ASSAY, APTIMA, 100T, IVD | PRD-05189 | APTIMA | HOLOGIC, INC. | |
18 | 15420045512054 | BV CONTROLS, APTIMA, 100T, IVD | PRD-05187 | APTIMA | HOLOGIC, INC. | |
19 | 15420045512047 | BV CALIBRATOR, APTIMA, 100T, IVD | PRD-05188 | APTIMA | HOLOGIC, INC. | |
20 | 15420045512030 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
21 | 15420045512023 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
22 | 15420045506701 | INVADER FACTOR V, 1680 TESTS | 95-457 | None | INVADER | HOLOGIC, INC. |
23 | 15420045506664 | INVADER FACTOR V, 144 TESTS | 95-453 | None | INVADER | HOLOGIC, INC. |
24 | M70870049330 | 70-04933 | Instrument is a multiplex instrument that uses molecular amplification and magne Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing. | T2Dx® | T2 BIOSYSTEMS, INC. | |
25 | 10888234401124 | 888302 | 888302 | LIFECODES Fluoroanalyzer | IMMUCOR GTI DIAGNOSTICS, INC. | |
26 | 10888234102670 | 800-20301 | 800-20301 | Carrier Box, ETC, Slide, IVD | BIOARRAY SOLUTIONS LTD | |
27 | 10888234102236 | 790-20016-RF | 790-20016-RF | BioArray Assay Imaging System TM (AIS) 400D | BIOARRAY SOLUTIONS LTD | |
28 | 10888234102229 | 790-20016 | 790-20016 | BioArray Assay Imaging System TM (AIS) 400D | BIOARRAY SOLUTIONS LTD | |
29 | 10888234102212 | 790-20006-RF | 790-20006-RF | BioArray Assay Imaging System TM (AIS) 400C | BIOARRAY SOLUTIONS LTD | |
30 | 10888234102205 | 790-20006 | 790-20006 | BioArray Assay Imaging SystemTM (AIS) 400C | BIOARRAY SOLUTIONS LTD | |
31 | 10190302000222 | 7503 | 7500 Fast Dx Real-Time PCR Instrument | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
32 | 08430793040532 | 724120 | 1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives | Aptiva® Celiac Disease IgA Reagent | INOVA DIAGNOSTICS, INC. | |
33 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | Xpert HemosIL FII & FV | CEPHEID |
34 | 07332940000240 | GXFIIFV-10 | GXFIIFV-10 | Xpert Factor II & Factor V kit; 10 test kit | Xpert Factor II & Factor V | CEPHEID |
35 | 05700571108703 | G5761A | SureScan Dx Microarray Scanner | SureScan Dx Microarray Scanner | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
36 | 04038377021591 | 1 | 04618955001 | Factor II Prothrombin G20210A Kit | ROCHE DIAGNOSTICS GMBH | |
37 | 03610520550984 | 1844095-IVD | 1844095-IVD | CFX96 Dx and CFX96 Deep Well Dx Systems | CFX96 | BIO-RAD LABORATORIES, INC. |
38 | 03610520540695 | version 4.3 | 12000964 | BioPlex 2200 Operation Manual version 4.3 Multiple Language CD-ROM | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
39 | 03610520540633 | SW Version 4.3 | 12000958 | BioPlex 2200 System Operation Manual , Software Version 4.3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
40 | 03610520505915 | SW Version 4.2 | 6600813-4.2.1 | BioPlex 2200 System Operation Manual , Software Version 4.2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
41 | 03610520457818 | 1845097-IVD | 1845097-IVD | CFX96 Dx and CFX96 Deep Well Dx Systems | CFX96 | BIO-RAD LABORATORIES, INC. |
42 | 03610520010167 | 660-0818 | 6600818 | BioPlex 2200 Instrument Wash Buffer, 1 X 10 L | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
43 | 03610520010150 | 660-0817 | 6600817 | BioPlex 2200 Instrument Sheath Fluid, 2 X 4L | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
44 | 00875197005998 | 07948352190 | 07948352190 | cobas Factor II and Factor V Test | ROCHE MOLECULAR SYSTEMS, INC. | |
45 | 00875197005561 | 07557272190 | 07557272190 | cobas omni Utility Channel Reagent Kit | ROCHE DIAGNOSTICS GMBH | |
46 | 00875197005134 | 07002238190 | 07002238190 | cobas® Buffer Negative Control Kit | ROCHE DIAGNOSTICS GMBH | |
47 | 00860006465612 | Azure Cielo 6 Dx | Azure Cielo Dx | AZURE BIOSYSTEMS INC. | ||
48 | 00860006465605 | Azure Cielo 3 Dx | Azure Cielo Dx | AZURE BIOSYSTEMS INC. | ||
49 | 00859812006065 | NCT-PREP-STATION-FLEX | NCT-PREP-STATION-FLEX | The Prep Station is a part of the nCounter DX Analysis System, which consists of The Prep Station is a part of the nCounter DX Analysis System, which consists of two instruments, the nCounter Prep Station 5s and the nCounter Digital Analyzer 5s. The Prep Station is the automated fluidic handling component of the nCounter DX Analysis System which processes samples post-hybridization. The samples prepared by the Prep Station are used for data collection on the nCounter Digital Analyzer. Together,the NanoString nCounter DX Analysis System (liquid handling robot and epifluorescence scanner) delivers direct, multiplexed measurements of gene expression through digital readouts of the relative abundance of mRNA transcripts using the following steps: 1) a hybridization of the mRNA to fluorescent Reporter Probes and Capture Probes, 2) purification of the target/probe complexes using nCounter Prep Plates containing reagents necessary for post-hybridization processing and immobilization onto the nCounter Cartridge on the nCounter Prep Station, and 3) analysis of the nCounter Cartridge on the nCounter Digital Analyzer to provide a test result. | nCounter Prep Station 5s | NANOSTRING TECHNOLOGIES, INC. |
50 | 00859812006003 | NCT-DIGITAL-ANALYZER-FLEX | NCT-DIGITAL-ANALYZER-FLEX | The Digital analyzer is a part of the nCounter DX Analysis System, which consist The Digital analyzer is a part of the nCounter DX Analysis System, which consists of two instruments, the nCounter Prep Station 5s and the nCounter Digital Analyzer 5s. The Digital Analyzer is a multi-channel epifluorescence scanner configured specifically for use with NanoString’s nCounter Test Kit Cartridges.The nCounter Digital Analyzer collects data by taking images of the immobilized fluorescent reporters in the sample cartridge with a CCD camera through a microscope objective lens. Together,the NanoString nCounter DX Analysis System (liquid handling robot and epifluorescence scanner) delivers direct, multiplexed measurements of gene expression through digital readouts of the relative abundance of mRNA transcripts using the following steps: 1) a hybridization of the mRNA to fluorescent Reporter Probes and Capture Probes, 2) purification of the target/probe complexes using nCounter Prep Plates containing reagents necessary for post-hybridization processing and immobilization onto the nCounter Cartridge on the nCounter Prep Station, and 3) analysis of the nCounter Cartridge on the nCounter Digital Analyzer to provide a test result. | nCounter Digital Analyzer 5s | NANOSTRING TECHNOLOGIES, INC. |