No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30014613336754 | RPS-ID-20-U | RPS-ID-20-U | InflammaDry | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | InflammaDry |
2 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | PFQ,JJX | MMP-9 test system,Single (specified) analyte controls (assayed and unassayed) | 1 | InflammaDry |
3 | 30014613336402 | Trichomonas Assay | M304.U | SolanaTrichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
4 | 30014613336396 | Trichomonas Assay | M304.S | Solana Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
5 | 30014613336082 | Group A Strep Assay | M301 | Solana GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Solana |
6 | 30014613335580 | C1-Inhibitor | A037 | MicroVue C1-Inhibitor Plus EIA | DBA | COMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
7 | 30014613335573 | Bp Plus EIA | A027 | Kit, Quidel Bb Plus | JZH | FACTOR B, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
8 | 30014613335566 | CH50 Eq EIA | A018 | MicroVue CH50 Eq EIA | DAE | COMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
9 | 30014613335559 | CIC-C1q Controls | A013 | MicroVue CIC-C1q Ctrls | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
10 | 30014613335542 | CIC-Raji EIA | A002 | MicroVue CIC-Raji EIA | CZY | COMPLEMENT C1S, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
11 | 30014613335535 | CIC-C1q EIA | A001 | MicroVue CIC-C1q EIA | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
12 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MRG | SYSTEM, TEST, VITAMIN D | 2 | MicroVue |
13 | 30014613333944 | PTH EIA | 8044 | MicroVue PTH EIA | CEW | RADIOIMMUNOASSAY, PARATHYROID HORMONE | 2 | MicroVue |
14 | 30014613333937 | Calcitonin EIA | 8043 | MicroVue Calcitonin EIA | JKR | RADIOIMMUNOASSAY, CALCITONIN | 2 | MicroVue |
15 | 30014613333920 | BAP EIA | 8012 | MicroVue BAP EIA | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | MicroVue |
16 | 30014613333913 | PYD EIA | 8010 | Kit, McVu PYD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
17 | 30014613333906 | DPD EIA | 8007 | Kit, McVu DPD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
18 | 30014613311140 | Parainfluenza Virus Assay | M114 | Lyra Parainfluenza Assay | OOU | Parainfluenza multiplex nucleic acid assay | 2 | Lyra |
19 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | OCC | Respiratory virus panel nucleic acid assay system | 2 | Lyra |
20 | 30014613311126 | Direct Strep Assay | M112 | Lyra Direct Strep Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Lyra |
21 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | OZN,OOI | C.Difficile toxin gene amplification assay,real time Nucleic acid amplification system | 2 | Lyra |
22 | 30014613311027 | Direct HSV 1+2/VZV Assay | M102 | Lyra Direct HSV 1+2/VZV Assay | PGI | Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutane | 2 | Lyra |
23 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
24 | 30014613003434 | 00343 | 00343 | QkVue InLine Strep A 25T | GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
25 | 30014613336686 | RPS-AD | RPS-AD | AdenoPlus | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | AdenoPlus |
26 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
27 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
28 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
29 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
30 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
31 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
32 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
33 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
35 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
36 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
37 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | OZZ | Bordetella pertussis dna assay system | 2 | AmpliVue |
38 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
39 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
40 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
41 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
42 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201939 | 20193 | 20193 | QkVue RSV 20T | MCE,GQG | RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRA | 1 | QuickVue |
48 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
49 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
50 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00628055420101 | 01004880-ABC (20) | 01004880-ABC (20) | A box of 20 SNP CYP2C19 External Control Kits. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
2 | 00628055420095 | 01004880-ABC (10) | 01004880-ABC (10) | A box of 10 CYP2C19 External Control Kits. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
3 | 00628055420088 | 01004872-ABC | 01004872-ABC | A box of 20 CYP2C19 Sample Collection Kits. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
4 | 00628055420071 | 01004985 | 01004985 | This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
5 | 00628055420064 | 01004985 | 01004985 | This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan R | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
6 | 00628055420057 | 01003374, 01003372, and 01003373 | 01003374, 01003372, and 01003373 | The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 Syst | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
7 | 00628055420040 | 01003359 | 01003359 | Barcode Scanner supplied with the Spartan RX CYP2C19 System. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
8 | 00628055420033 | 01003438 | 01003438 | Printer supplied with the Spartan RX CYP2C19 System | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
9 | 00628055420026 | 01003214 | 01003214 | Netbook supplied with the Spartan RX CYP2C19 System. | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
10 | 00628055420019 | 01004777 | 01004777 | Spartan RX Analyzer | Spartan RX CYP2C19 System | SPARTAN BIOSCIENCE INC |
11 | 00382904437121 | 443712 | 443712 | BD MAX™ Vaginal Panel | BD MAX™ Vaginal Panel | BECTON, DICKINSON AND COMPANY |
12 | B769ICRADAA00000 | iCR-ADAA00000 | The iC-System is an in vitro diagnostic device designed to perform multiplex amp | iC-Reader | ICUBATE, INC | |
13 | B769ICPADAAA0000 | iCP-ADAAA0000 | The iC-System is an in vitro diagnostic device designed to perform multiplex amp | iC-Processor | ICUBATE, INC | |
14 | B550ENT0100 | Quality Control Tray | ENT010 | Metal tray used for quality control of OpsisDx heater | OpsisDx | ENTOPSIS, LLC |
15 | B550ENT0070 | Testing Tray | ENT007 | Metal tray used to heat OpsisDx NuTec Slides | OpsisDx | ENTOPSIS, LLC |
16 | B550ENT0040 | Standard Media | ENT004 | Media used for quality control of the OpsisDx platform | OpsisDx | ENTOPSIS, LLC |
17 | B550ENT0020 | Signal Enhancer | ENT002 | Additive used in preparing OpsisDx urine fixative and OpsisDx standard media | OpsisDx | ENTOPSIS, LLC |
18 | B550ENT0010 | NuTec Chamber | ENT001 | Four NuTec slides used to create bio-molecular profiles of samples | OpsisDx | ENTOPSIS, LLC |
19 | B3959930030 | 9930030 | 9930030 | NMR Reference Standard used for the Vantera Clinical Analyzer. | NMR Reference Standard | LABCORP OF AMERICA |
20 | B3959920030 | 9920030 | 9920030 | Sample Diluent 1 used for the Vantera Clinical Analyzer. | NMR Diluent 1 | LABCORP OF AMERICA |
21 | B3959910030 | 9910030 | 9910030 | WASH Solution used for the Vantera Clinical Analyzer | NMR WASH Solution | LABCORP OF AMERICA |
22 | B3959900300 | 9900300 | 9900300 | Clinical Analyzer | Vantera Clinical Analyzer | LABCORP OF AMERICA |
23 | B178PA5000 | PA500 | PA500 | PA500 Portrait Analyzer | GREAT BASIN SCIENTIFIC, INC. | |
24 | 30014613202783 | 20278 | 20278 | Solana instrument | Solana | QUIDEL CORPORATION |
25 | 15420045512092 | CV/TV CONTROLS, APTIMA, 100T, IVD | PRD-05190 | APTIMA | HOLOGIC, INC. | |
26 | 15420045512085 | CV/TV CALIBRATOR, APTIMA, 100T, IVD | PRD-05191 | APTIMA | HOLOGIC, INC. | |
27 | 15420045512078 | CV/TV ASSAY, APTIMA, 100T, IVD | PRD-05189 | APTIMA | HOLOGIC, INC. | |
28 | 15420045512061 | CV/TV ASSAY, APTIMA, 100T, IVD | PRD-05189 | APTIMA | HOLOGIC, INC. | |
29 | 15420045512054 | BV CONTROLS, APTIMA, 100T, IVD | PRD-05187 | APTIMA | HOLOGIC, INC. | |
30 | 15420045512047 | BV CALIBRATOR, APTIMA, 100T, IVD | PRD-05188 | APTIMA | HOLOGIC, INC. | |
31 | 15420045512030 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
32 | 15420045512023 | BV ASSAY, APTIMA, 100T, IVD | PRD-05186 | APTIMA | HOLOGIC, INC. | |
33 | M70870049330 | 70-04933 | Instrument is a multiplex instrument that uses molecular amplification and magne | T2Dx® | T2 BIOSYSTEMS, INC. | |
34 | 10888234401124 | 888302 | 888302 | LIFECODES Fluoroanalyzer | IMMUCOR GTI DIAGNOSTICS, INC. | |
35 | 10888234102670 | 800-20301 | 800-20301 | Carrier Box, ETC, Slide, IVD | BIOARRAY SOLUTIONS LTD | |
36 | 10888234102236 | 790-20016-RF | 790-20016-RF | BioArray Assay Imaging System TM (AIS) 400D | BIOARRAY SOLUTIONS LTD | |
37 | 10888234102229 | 790-20016 | 790-20016 | BioArray Assay Imaging System TM (AIS) 400D | BIOARRAY SOLUTIONS LTD | |
38 | 10888234102212 | 790-20006-RF | 790-20006-RF | BioArray Assay Imaging System TM (AIS) 400C | BIOARRAY SOLUTIONS LTD | |
39 | 10888234102205 | 790-20006 | 790-20006 | BioArray Assay Imaging SystemTM (AIS) 400C | BIOARRAY SOLUTIONS LTD | |
40 | 10190302000222 | 7503 | 7500 Fast Dx Real-Time PCR Instrument | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
41 | 08430793040532 | 724120 | 1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 | Aptiva® Celiac Disease IgA Reagent | INOVA DIAGNOSTICS, INC. | |
42 | 05700571108703 | G5761A | SureScan Dx Microarray Scanner | SureScan Dx Microarray Scanner | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
43 | 03610520550984 | 1844095-IVD | 1844095-IVD | CFX96 Dx and CFX96 Deep Well Dx Systems | CFX96 | BIO-RAD LABORATORIES, INC. |
44 | 03610520540695 | version 4.3 | 12000964 | BioPlex 2200 Operation Manual version 4.3 Multiple Language CD-ROM | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
45 | 03610520540633 | SW Version 4.3 | 12000958 | BioPlex 2200 System Operation Manual , Software Version 4.3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 03610520505915 | SW Version 4.2 | 6600813-4.2.1 | BioPlex 2200 System Operation Manual , Software Version 4.2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
47 | 03610520457818 | 1845097-IVD | 1845097-IVD | CFX96 Dx and CFX96 Deep Well Dx Systems | CFX96 | BIO-RAD LABORATORIES, INC. |
48 | 03610520010167 | 660-0818 | 6600818 | BioPlex 2200 Instrument Wash Buffer, 1 X 10 L | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
49 | 03610520010150 | 660-0817 | 6600817 | BioPlex 2200 Instrument Sheath Fluid, 2 X 4L | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00875197005561 | 07557272190 | 07557272190 | cobas omni Utility Channel Reagent Kit | ROCHE DIAGNOSTICS GMBH |