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 Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples | 2 | Lyra |
23 | 30014613202783 | 20278 | 20278 | Solana instrument | NSU | Instrumentation for clinical multiplex test systems | 2 | Solana |
24 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
25 | 30014613003434 | 00343 | 00343 | QkVue InLine Strep A 25T | GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
26 | 30014613336686 | RPS-AD | RPS-AD | AdenoPlus | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | AdenoPlus |
27 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
28 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
29 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
30 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
31 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
32 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
33 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
35 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
36 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
37 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
38 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | OZZ | Bordetella pertussis dna assay system | 2 | AmpliVue |
39 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
40 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
41 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
42 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
48 | 30014613201939 | 20193 | 20193 | QkVue RSV 20T | MCE,GQG | RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRA RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
49 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
50 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00608337000047 | 1001-0321 | OraSure Quickflu Nasopharyngeal Wash / Aspirate | ORASURE TECHNOLOGIES, INC. | ||
2 | 00382902560746 | 256074 | 256074 | BD Veritor™ Plus CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ Sys BD Veritor™ Plus CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066) | BD Veritor™ Plus CLIA-Waived Combo Pack | BECTON, DICKINSON AND COMPANY |
3 | 00382902560739 | 256073 | 256073 | BD Veritor™ System Laboratory Combo Pack Contains: 2xBD Veritor ™ Sy BD Veritor™ System Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066) | BD Veritor™ System Laboratory Combo Pack | BECTON, DICKINSON AND COMPANY |
4 | 00382902560715 | 256071 | 256071 | BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ S BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055) | BD Veritor™ System CLIA-Waived Combo Pack | BECTON, DICKINSON AND COMPANY |
5 | 00382902560708 | 256070 | 256070 | BD Veritor™ Plus Laboratory Combo Pack Contains: 2xBD Veritor ™ Syst BD Veritor™ Plus Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ System Reader (Cat. No. 256055) | BD Veritor™ Plus Laboratory Combo Pack | BECTON, DICKINSON AND COMPANY |
6 | 00382902560456 | 256045 | 256045 | BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit Contains: 30 e BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit Contains: 30 each Flu A+B Device, RV Reagent D unitized Tubes, Flu A+/B- Control Swabs, Flu B=/A- Control Swabs. | BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit | BECTON, DICKINSON AND COMPANY |
7 | 00382902560418 | 256041 | 256041 | BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit Contains: 30 ea BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit Contains: 30 each, Flu A+B Device, RV Reagent C unitized tubes, Flu A+/B- Control Swabs, Flu B+/A- Control Swabs. | BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit | BECTON, DICKINSON AND COMPANY |
8 | 00304040019771 | 1126219 | 1126219 | Rapid test for the quantitative detection of Influenza A&B antigens in nasal swa Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens | Henry Schein | HENRY SCHEIN, INC. |
9 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | QuickVue | QUIDEL CORPORATION |
10 | 30014613202547 | 20254 | 20254 | Sofia Flu A+B 25T | Sofia | QUIDEL CORPORATION |
11 | 30014613202189 | 20218 | 20218 | Sofia Flu A+B 25T | Sofia | QUIDEL CORPORATION |
12 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | QuickVue | QUIDEL CORPORATION |
13 | 30014613003175 | 00317 | 00317 | QkVue Flu Bulk 25T | QuickVue | QUIDEL CORPORATION |
14 | 20612479226795 | 181-36026 | Influenza A & B Test NASOPHARYNGEAL WASH/ASPIRATE KIT | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
15 | 20612479225118 | 181-36025 | Influenza A & B Test | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
16 | 20608337000065 | 1001-0320 | OraSure Quick Flu 22-Count Flu A + B Kit | ORASURE TECHNOLOGIES, INC. | ||
17 | 10743816001508 | BSP-510-25-02 | BSP-510-25-02 | Status Flu A+B; 25 Test Kit | Status Flu A+B card | PRINCETON BIOMEDITECH CORPORATION |
18 | 10743816001478 | BSP-510-25-01 | BSP-510-25-01 | BioSign Flu A+B; 25 Test Kit | BioSign Flu A+B card | PRINCETON BIOMEDITECH CORPORATION |
19 | 10743816001447 | BSP-510-05-00 | BSP-510-05-00 | Status Flu A+B; 5 Test Kit | Status Flu A & B | PRINCETON BIOMEDITECH CORPORATION |
20 | 10743816001430 | BSP-510-22-08 | BSP-510-22-08 | Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Regular Swabs | Status Flu A+B Validation Kit | PRINCETON BIOMEDITECH CORPORATION |
21 | 10743816001416 | BSP-510AS-04 | BSP-510AS-04 | Status Flu A+B Nasopharyngeal Wash/Aspirate Kit; 44 Pipettes | Status Flu A+B Nasal Wash/Aspirate Kit | PRINCETON BIOMEDITECH CORPORATION |
22 | 10743816001218 | BSP-510-04-00 | BSP-510-04-00 | Status Flu A & B; 4 Test Sample Kit | Status Flu A+B card | PRINCETON BIOMEDITECH CORPORATION |
23 | 10743816001201 | BSP-510-10-00 | BSP-510-10-00 | BioSign Flu A+B; 10 Test Kit; CE | BioSign Flu A+B card | PRINCETON BIOMEDITECH CORPORATION |
24 | 10743816001195 | BSP-510-22-01 | BSP-510-22-01 | Status Flu A+B; 22 Test Kit | Status Flu A+B card | PRINCETON BIOMEDITECH CORPORATION |
25 | 10743816001188 | BSP-510-22-00 | BSP-510-22-00 | BioSign Flu A+B; 22 Test Kit | BioSign Flu A+B card | PRINCETON BIOMEDITECH CORPORATION |
26 | 00855574005407 | FLU22 | Flu A & B, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
27 | 00848838063701 | R246003 | Xpect Flu A&B Control 20Swab/SET | Remel | REMEL, INC. | |
28 | 00816917022925 | FLU25 | Flu A & B, Immunochromatographic, 25 Test Kit | Poly stat | POLYMEDCO, INC. | |
29 | 00742860100215 | 1005 | 1005 | OSOM Ultra Flu A&B Controls 5 Test | OSOM Ultra Flu A&B Controls 5 Test | SEKISUI DIAGNOSTICS, LLC |
30 | 00742860100147 | 191 | 191 | OSOM Influenza Control Kit | SEKISUI DIAGNOSTICS, LLC | |
31 | 00742860001901 | 190 | 190 | OSOM Flu Dipstick 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
32 | 00722066003343 | FLUab-19C15 | FLUab-19C15 | Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitat Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens. | Rapid Response | BTNX INC |