| 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 | 00850009370051 | 01-2020-01 | 01-2020-01 | Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation | 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 Intellipac® Reagent Module |
| 7 | 00850009370006 | 10-0020-99 | 10-0020-99 | Instrumentation For Clinical Multiplex Test Systems | NSU | Instrumentation for clinical multiplex test systems | 2 | INFINITI® PLUS ANALYZER |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00815381029089 | HTFA-ASY-0003-W | Refurbished IVD Instrument (FilmArray® Torch Module) | FilmArray® Torch Module | BIOFIRE DIAGNOSTICS, LLC | |
| 2 | 00815381029072 | HTFA-ASY-0001-W | Refurbished IVD Instrument (FilmArray® Torch System Base) | FilmArray® Torch System Base | BIOFIRE DIAGNOSTICS, LLC | |
| 3 | 00815381029058 | FLM2-ASY-0001-W | Refurbished IVD Instrument (FilmArray® 2.0 Instrument). | FilmArray® 2.0 Instrument | BIOFIRE DIAGNOSTICS, LLC | |
| 4 | 00815381020307 | RFIT-ASY-0137 | RFIT-ASY-0137 | IVD reagent kit containing 6 tests | FilmArray® Respiratory Panel 2 plus (RP2plus) | BIOFIRE DIAGNOSTICS, LLC |
| 5 | 00815381020291 | RFIT-ASY-0136 | RFIT-ASY-0136 | IVD reagent kit containing 30 tests | FilmArray® Respiratory Panel 2 plus (RP2plus) | BIOFIRE DIAGNOSTICS, LLC |
| 6 | 00815381020284 | HTFA-SUB-0103 | HTFA-SUB-0103R | Refurbished IVD instrument (Torch Module) | FilmArray® Torch Module | BIOFIRE DIAGNOSTICS, LLC |
| 7 | 00815381020277 | HTFA-SUB-0103 | HTFA-SUB-0103 | IVD Instrument (FilmArray® Torch Module). | FilmArray® Torch Module | BIOFIRE DIAGNOSTICS, LLC |
| 8 | 00815381020260 | HTFA-ASY-0104 | HTFA-ASY-0104R | Refurbished IVD Instrument (FilmArray® Torch System Base). | FilmArray® Torch System Base | BIOFIRE DIAGNOSTICS, LLC |
| 9 | 00815381020253 | HTFA-ASY-0104 | HTFA-ASY-0104 | IVD Instrument (FilmArray® Torch System Base). | FilmArray® Torch System Base | BIOFIRE DIAGNOSTICS, LLC |
| 10 | 00815381020048 | FLM2-ASY-0001 | FLM2-ASY-0001R | Refurbished IVD Instrument (FilmArray® 2.0 Instrument). | FilmArray® 2.0 Instrument | BIOFIRE DIAGNOSTICS, LLC |
| 11 | 00815381020031 | FLM2-ASY-0001 | FLM2-ASY-0001 | IVD Instrument (FilmArray® 2.0 Instrument). | FilmArray® 2.0 Instrument | BIOFIRE DIAGNOSTICS, LLC |
| 12 | 00815381020024 | FLM1-ASY-0001 | FLM1-ASY-0001R | Refurbished IVD Instrument (FilmArray® Instrument). | FilmArray® Instrument | BIOFIRE DIAGNOSTICS, LLC |
| 13 | 00815381020017 | FLM1-ASY-0001 | FLM1-ASY-0001 | IVD Instrument (FilmArray® Instrument) | FilmArray® Instrument | BIOFIRE DIAGNOSTICS, LLC |
| 14 | 00814695022588 | N/A | LABSCNXS4 | Dual syringe pumps and reagent reservoirs allow for higher throughput and planne Dual syringe pumps and reagent reservoirs allow for higher throughput and planned maintenance routines. With its ability to process 500 bead regions simultaneously, there is significant increase in the size of screenable analytes. | LABScan3D™ | ONE LAMBDA, INC. |
| 15 | 00812117015699 | N/A | LABSCNXS2 | A sensitive flow analyzer capable of processing up to 100 bead regions simultane A sensitive flow analyzer capable of processing up to 100 bead regions simultaneously and when used with One Lambda’s LABType and LABScreen family of products, the system allows the user to make assignments of HLA antibodies as well as HLA typing with the analysis support of HLA Fusion. | LABScan™ 100 Systems | ONE LAMBDA, INC. |
| 16 | 00628055420101 | 01004880-ABC (20) | 01004880-ABC (20) | A box of 20 SNP CYP2C19 External Control Kits. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 17 | 00628055420095 | 01004880-ABC (10) | 01004880-ABC (10) | A box of 10 CYP2C19 External Control Kits. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 18 | 00628055420088 | 01004872-ABC | 01004872-ABC | A box of 20 CYP2C19 Sample Collection Kits. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 19 | 00628055420071 | 01004985 | 01004985 | This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438). | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 20 | 00628055420064 | 01004985 | 01004985 | This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan R This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359). | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 21 | 00628055420057 | 01003374, 01003372, and 01003373 | 01003374, 01003372, and 01003373 | The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 Syst The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373). | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 22 | 00628055420040 | 01003359 | 01003359 | Barcode Scanner supplied with the Spartan RX CYP2C19 System. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 23 | 00628055420033 | 01003438 | 01003438 | Printer supplied with the Spartan RX CYP2C19 System | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 24 | 00628055420026 | 01003214 | 01003214 | Netbook supplied with the Spartan RX CYP2C19 System. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 25 | 00628055420019 | 01004777 | 01004777 | Spartan RX Analyzer | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
| 26 | 00382904437121 | 443712 | 443712 | BD MAX™ Vaginal Panel | BD MAX™ Vaginal Panel | BECTON, DICKINSON AND COMPANY |
| 27 | 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 | |
| 28 | 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 | |
| 29 | B550ENT0100 | Quality Control Tray | ENT010 | Metal tray used for quality control of OpsisDx heater | OpsisDx | ENTOPSIS, LLC |
| 30 | B550ENT0070 | Testing Tray | ENT007 | Metal tray used to heat OpsisDx NuTec Slides | OpsisDx | ENTOPSIS, LLC |
| 31 | B550ENT0040 | Standard Media | ENT004 | Media used for quality control of the OpsisDx platform | OpsisDx | ENTOPSIS, LLC |
| 32 | B550ENT0020 | Signal Enhancer | ENT002 | Additive used in preparing OpsisDx urine fixative and OpsisDx standard media | OpsisDx | ENTOPSIS, LLC |
| 33 | B550ENT0010 | NuTec Chamber | ENT001 | Four NuTec slides used to create bio-molecular profiles of samples | OpsisDx | ENTOPSIS, LLC |
| 34 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
| 35 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
| 36 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
| 37 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |
| 38 | B178PA5000 | PA500 | PA500 | PA500 Portrait Analyzer | GREAT BASIN SCIENTIFIC, INC. | |
| 39 | 30014613202783 | 20278 | 20278 | Solana instrument | Solana | QUIDEL CORPORATION |
| 40 | 15420045512092 | CV/TV CONTROLS, APTIMA, 100T, IVD | PRD-05190 | APTIMA | HOLOGIC, INC. | |
| 41 | 15420045512085 | CV/TV CALIBRATOR, APTIMA, 100T, IVD | PRD-05191 | APTIMA | HOLOGIC, INC. | |
| 42 | 15420045512078 | CV/TV ASSAY, APTIMA, 100T, IVD | PRD-05189 | APTIMA | HOLOGIC, INC. | |
| 43 | 15420045512061 | CV/TV ASSAY, APTIMA, 100T, IVD | PRD-05189 | APTIMA | HOLOGIC, INC. | |
| 44 | 15420045512054 | BV CONTROLS, APTIMA, 100T, IVD | PRD-05187 | APTIMA | HOLOGIC, INC. | |
| 45 | 15420045512047 | BV CALIBRATOR, APTIMA, 100T, IVD | PRD-05188 | APTIMA | HOLOGIC, INC. | |
| 46 | 15420045512030 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
| 47 | 15420045512023 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
| 48 | 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. | |
| 49 | 10888234401124 | 888302 | 888302 | LIFECODES Fluoroanalyzer | IMMUCOR GTI DIAGNOSTICS, INC. | |
| 50 | 10888234102670 | 800-20301 | 800-20301 | Carrier Box, ETC, Slide, IVD | BIOARRAY SOLUTIONS LTD |