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 | 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 RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 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 | 00742860100116 | 148 | 148 | OSOM Ultra Strep A 5 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
2 | 00742860001499 | 149 | 149 | OSOM Ultra Strep A 50 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
3 | 00742860001475 | 147 | 147 | OSOM Ultra Strep A 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
4 | 00722066000014 | STR-15S25 | STR-15S25 | Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualita Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens. | Rapid Response | BTNX INC |
5 | 00695684730406 | 73040 | A rapid dipstick test for the qualitative detection of group A streptococcal ant A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs. | STREPAIM | GERMAINE LABORATORIES, INC | |
6 | 00695684730253 | 73025 | A rapid dipstick test for the qualitative detection of group A streptococcal ant A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs. | STREPAIM | GERMAINE LABORATORIES, INC | |
7 | 00657498600023 | 6000-050 | 6000-050 | A rapid test for the qualitative detection of Strep A antigen in throat swab specimens. | QuSTICK™ Strep A | STANBIO LABORATORY, L.P. |
8 | 00657498600016 | 6000-025 | 6000-025 | A rapid test for the qualitative detection of Strep A antigen in throat swab specimens. | QuSTICK™ Strep A | STANBIO LABORATORY, L.P. |
9 | 00613647000557 | 4581455021 | 23900532 | SURE-VUE STREP A 27/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
10 | 00613647000298 | 23-200-276 | 23200276 | Sure-Vue Signature Strep A | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
11 | 00612479242869 | 181-34125 | Status Strep A Flip | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
12 | 00612479202733 | 5003 | TEST, KIT STREP A DIPSTICK WAI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
13 | 00612479202726 | 4999 | TEST, KIT STREP A DIPSTICK WAI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
14 | 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 |
15 | 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 |
16 | 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 |
17 | 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 |
18 | 00382902560401 | 256040 | 256040 | BD Veritor™ System For Rapid Detection of Group A Strep Contains: 30 Strep BD Veritor™ System For Rapid Detection of Group A Strep Contains: 30 Strep A Devices, 30 GAS Reagent 2 in unitized tubes, 30 individually wrapped, sterile throat swabs, one 4 mL dropper bottle GAS Reagent 1, one each of positive and negative control swabs | BD Veritor™ System For Rapid Detection of Group A Strep - CLIA waived kit | BECTON, DICKINSON AND COMPANY |
19 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | QuickVue | QUIDEL CORPORATION |
20 | 30014613202769 | 20276 | 20276 | Sofia Strep A+ 25T | Sofia | QUIDEL CORPORATION |
21 | 30014613202745 | 20274 | 20274 | Sofia Strep A+ 25T, US | Sofia | QUIDEL CORPORATION |
22 | 30014613202530 | 20253 | 20253 | Sofia Strep A 25T, US | Sofia | QUIDEL CORPORATION |
23 | 30014613202318 | 20231 | 20231 | Sofia Strep A 25T | Sofia | QUIDEL CORPORATION |
24 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | QuickVue | QUIDEL CORPORATION |
25 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | QuickVue | QUIDEL CORPORATION |
26 | 30014613201083 | 20108 | 20108 | QkVue Strep A Dpstk 50T | QuickVue | QUIDEL CORPORATION |
27 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | QuickVue In-Line | QUIDEL CORPORATION |
28 | 20885380183628 | CH27 | CH27 | CH27 - Strep A Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
29 | 20885380106955 | B1077-40 | B1077-40 | STREP A CASSETTE RAPID TEST | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
30 | 20885380059138 | B1077-30 | B1077-30 | Strep A Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
31 | 15099590625955 | 395161 | 395161 | ICON SC Strep A Kit, 25 Tests | Icon | BECKMAN COULTER, INC. |
32 | 15099590625931 | 395098 | 395098 | ICON DS STREP A, 25 TEST BOX | Icon | BECKMAN COULTER, INC. |
33 | 10859035006221 | 46050 | Wampole ColorCard® Streptozyme® | ALERE NORTH AMERICA, LLC | ||
34 | 10815845020055 | 01P46-50 | Signify® | ALERE SAN DIEGO, INC. | ||
35 | 10815845020031 | 92001 | Acceava® | ALERE SAN DIEGO, INC. | ||
36 | 10815845020024 | 92002 | Clearview® | ALERE SAN DIEGO, INC. | ||
37 | 10763924513199 | ID513 | Strep A Rapid Test Strip (Throat Swab) | Accutest Value+ Strep A Rapid Test Strip | JANT PHARMACAL CORPORATION | |
38 | 10743816000907 | BSP-185-30-06 | BSP-185-30-06 | BioStrep® A strip; 30 Test kit; CE; for LifeSign (Infolab) | BioStrep® A | PRINCETON BIOMEDITECH CORPORATION |
39 | 10743816000891 | BSP-185-30-04 | BSP-185-30-04 | BioStrep® A strip; 30 Test kit; CE | BioStrep® A | PRINCETON BIOMEDITECH CORPORATION |
40 | 10743816000884 | BSP-185-12-00 | BSP-185-12-00 | Status Strep A strip; 12 Test sample kit | Status Strep A strip | PRINCETON BIOMEDITECH CORPORATION |
41 | 10743816000877 | BSP-185-30-01 | BSP-185-30-01 | Status Strep A strip; 30 Test kit | Status Strep A strip | PRINCETON BIOMEDITECH CORPORATION |
42 | 10743816000860 | BSP-185-05-00 | BSP-185-05-00 | Status Strep A Plus; 5 Test kit (5 Test Strip Canister) | Status Strep A Plus | PRINCETON BIOMEDITECH CORPORATION |
43 | 10743816000853 | BSP-185-50-01 | BSP-185-50-01 | Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister) | Status Strep A Plus | PRINCETON BIOMEDITECH CORPORATION |
44 | 10743816000846 | BSP-182-12-00 | BSP-182-12-00 | Status Strep A card; Flip cassette; 12 Test sample kit | Status Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |
45 | 10743816000839 | BSP-182-05-00 | BSP-182-05-00 | Status Strep A card; Flip cassette; 5 Test kit | Status Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |
46 | 10743816000822 | BSP-182-25-03 | BSP-182-25-03 | BioSign® Strep A card; Flip cassette; 25 Test kit; for LifeSign (Infolab) | BioSign® Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |
47 | 10743816000815 | BSP-182-25-02 | BSP-182-25-02 | BioSign® Strep A card; Flip cassette; 25 Test kit | BioSign® Strep A card | PRINCETON BIOMEDITECH CORPORATION |
48 | 10743816000808 | BSP-181-25-02 | BSP-181-25-02 | BioSign® Strep A card; 25 Test kit; CE | BioSign® Strep A card | PRINCETON BIOMEDITECH CORPORATION |
49 | 10743816000792 | BSP-181-25-01 | BSP-181-25-01 | Status AccuStrep A card; 25 Test kit | Status AccuStrep A card | PRINCETON BIOMEDITECH CORPORATION |
50 | 10743816000785 | BSP-182-25-00 | BSP-182-25-00 | Status Strep A card; Flip cassette; 25 Test kit | Status Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |