No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740200053 | 08P433C | 08P433C | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
2 | 00380740200060 | 09P271B | 09P271B | Alinity i Anti-CCP Assay File | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Alinity |
3 | 00380740200046 | 08P435C | 08P435C | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
4 | 00380740200039 | 08P431C | 08P431C | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
5 | 00380740200022 | 08P437C | 08P437C | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
6 | 00380740199487 | 04V511B | 04V511B | Alinity c Total Bilirubin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
7 | 00380740195458 | 07P701C | 07P701C | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
8 | 00380740195380 | 08P181B | 08P181B | Alinity c A-ALT Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
9 | 00380740194208 | 09P523B | 09P523B | Alinity c BenzSQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
10 | 00380740194192 | 09P521B | 09P521B | Alinity c BenzQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
11 | 00380740194093 | 06S611A | 06S611A | Alinity i COV 2IgGII Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
12 | 00380740193638 | 04Z211A | 04Z211A | Alinity i STAT High Sensitivity Tropopnin-I | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
13 | 00380740193577 | 07P701B | 07P701B | Alinity i Free T4 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
14 | 00380740192723 | 04U093A | 04U093A | Alinity c Uric2-U Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
15 | 00380740192464 | 06R911A | 06R911A | Alinity i COV-2 IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
16 | 00380740189105 | 08P013B | 08P013B | Alinity c CrEnzU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
17 | 00380740189099 | 08P011B | 08P011B | Alinity c CrEnz Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
18 | 00380740186418 | 04T843A | 04T843A | Alinity c ALT2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
19 | 00380740186401 | 04T841A | 04T841A | Alinity c ALT2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
20 | 00380740186395 | 04T863A | 04T863A | Alinity c AST2F Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
21 | 00380740186388 | 04T861A | 04T861A | Alinity c AST2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
22 | 00380740186364 | 04U091A | 04U091A | Alinity c Uric2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
23 | 00380740186265 | 04T961A | 04T961A | Alinity c GGT2 Asasy File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
24 | 00380740186159 | 04T811A | 04T811A | Alinity c TPRO2 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
25 | 00380740185978 | 07P569A | 07P569A | Alinity c CardiacCRP Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
26 | 00380740185787 | 09P261B | 09P261B | Alinity i Active B12 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
27 | 00380740181000 | 09P533A | 09P533A | Alinity c SerBENZQ Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
28 | 00380740180201 | 08P433B | 08P433B | Alinity c A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
29 | 00380740180195 | 08P435B | 08P435B | Alinity c %A1cWB Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
30 | 00380740180188 | 08P431B | 08P431B | Alinity c A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
31 | 00380740180171 | 08P437B | 08P437B | Alinity c %A1cH Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
32 | 00380740180164 | 08P541B | 08P541B | Alinity c Phenytoin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
33 | 00380740180157 | 08P591B | 08P591B | Alinity c Salicylate Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
34 | 00380740180140 | 08P193C | 08P193C | Alinity c MagnesiumU Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
35 | 00380740180133 | 08P191C | 08P191C | Alinity c Magnesium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
36 | 00380740180126 | 09P631B | 09P631B | Alinity c IgM Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
37 | 00380740180119 | 08P531D | 08P531D | Alinity c Lithium Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
38 | 00380740180089 | 08P041B | 08P041B | Alinity c Microalb Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
39 | 00380740180058 | 08P551B | 08P551B | Alinity c Gentamicin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
40 | 00380740180041 | 09P931B | 09P931B | Alinity c Cerulo Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
41 | 00380740180034 | 07P591B | 07P591B | Alinity c U/CSF Prot Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
42 | 00380740180027 | 07P751B | 07P751B | Alinity c Ultra HDL Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
43 | 00380740180010 | 07P771B | 07P771B | Alinity c Trig Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
44 | 00380740180003 | 09P861B | 09P861B | Alinity c Prealbumin Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
45 | 00380740179991 | 07P761B | 07P761B | Alinity c Chol Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
46 | 00380740179984 | 08P021B | 08P021B | Alinity c AlbuminBCG Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
47 | 00380740179977 | 07P691C | 07P691C | Alinity i Free T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
48 | 00380740179960 | 07P941C | 07P941C | Alinity i Total T3 Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
49 | 00380740179571 | 07P567A | 07P567A | Alinity c CRP WR Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
50 | 00380740179564 | 07P565A | 07P565A | Alinity c CRP HS Assay File | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04015630940356 | 07251378190 | 07251378190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
2 | 04015630934881 | 06923348190 | 06923348190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
3 | 03610522015597 | 12007240 | 12007240 | U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
4 | 03610522004980 | 12006863 | 12006863 | BioPlex 2200 Sample Dilution Buffer (1X), 120 mL | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
5 | 03610520992692 | 4.3 | 12000656 | U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
6 | 03610520653012 | 12000650 | 12000650 | BioPlex 2200 Syphilis Total & RPR Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
7 | 03610520138267 | 4.3_v1 | 12000657 | BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
8 | 00868926000302 | B012 | Syphilis Health Check | VEDALAB | ||
9 | 00850487007609 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
10 | 00850487007043 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
11 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
12 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 00847865002233 | SW4_V2 | 6651470D | Syphilis IgG Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 00847865002134 | SW4_V2 | 6651460E | Manual & CDs, BioPlex 2200, Syphilis IgG IFU, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
15 | 00847865000307 | 6651450 | 6651450 | Syphilis IgG Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
16 | 00630414976891 | 10471981 | L2KSY2(D) | Syphilis - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems SYP Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
17 | 00630414976709 | 10469595 | LCVGCM | CMV IgG - IMMULITE - CTL | IMMULITE® Systems CVG CONTROL CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
18 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | IMMULITE® Systems SYP CONTROL Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
19 | 00630414599892 | 10995676 | 10995676 | Syphillis (Syph) QC Kit Atellica IM - CLT 2 x 2 x 7.0mL | Atellica IM Syph QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
20 | 00630414599885 | 10995675 | 10995675 | Syphillis (Syph) Atellica IM - RGT 200T | Atellica IM Syph | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
21 | 00630414580173 | 10492493 | 10492493 | Syphilis - CENTAUR - RGT - 200 tests | ADVIA Centaur® SYPH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
22 | 00607158000083 | 65-9502-0 | The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection. | DPP HIV-Syphilis | CHEMBIO DIAGNOSTIC SYSTEMS INC. | |
23 | 00380740138332 | 07P6031 | 07P6031 | Alinity i Syphilis TP Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
24 | 00380740138196 | 07P6021 | 07P6021 | Alinity i Syphilis TP Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
25 | 00380740117122 | 8D06-41 | 08D0641 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
26 | 00380740117115 | 8D06-31 | 08D0631 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
27 | 00380740103545 | 8D06-13 | 08D0613 | ARCHITECT Syphilis TP Controls | ARCHITECT | ABBOTT GMBH |
28 | 00380740103538 | 8D06-04 | 08D0604 | ARCHITECT Syphilis TP Calibrator | ARCHITECT | ABBOTT GMBH |
29 | 07613336171998 | 09015051190 | 09015051190 | Syphilis Elecsys E2G 300 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
30 | 07613336171950 | 09014977190 | 09014977190 | Syphilis Elecsys cobas e 100 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
31 | 05391516748766 | 1206711 | 1206711 | Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
32 | 05391516748759 | 1206710 | 1206710 | Uni-Gold™ Syphilis Treponemal, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
33 | 05391516747462 | TS-96-E | TS-96-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
34 | 05391516747448 | TS-960-E | TS-960-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
35 | 05391516747431 | TS-960 | TS-960 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
36 | 05391516747424 | TS-96-Bulk | Trep Sure Bulk Kit | Phoenix Biotech | CLARK LABORATORIES, INC. | |
37 | 05391516747417 | TS-96 | TS-96 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
38 | 05391516747400 | TS-1920 | TS-1920 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
39 | 05391516747226 | 916401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
40 | 05391516746915 | 386470 | 386470 | Trep-Sure Conjugate | Phoenix Biotech | CLARK LABORATORIES, INC. |
41 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
42 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
43 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
44 | 05391516746847 | 525777 | 525777 | Trep-Sure Substrate | Phoenix Biotech | CLARK LABORATORIES, INC. |
45 | 05391516746694 | 72520 | 72520 | Syphilis IgM EIA | BIO-RAD | CLARK LABORATORIES, INC. |
46 | 05391516746687 | 72517 | 72517 | Wash Solution, x20 (Non US Sales Only) | Bio-Rad | CLARK LABORATORIES, INC. |
47 | 05391516746588 | YY60126 | Syphilis EIA (Non-US sales only) | Bio-Stat | CLARK LABORATORIES, INC. | |
48 | 05391516745109 | 2322171 | 2322171 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
49 | 05391516745093 | 2322170 | 2322170 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
50 | 05391516745048 | 2329360 | 2329360 | CAPTIA™ NMT Syphilis IgM | Trinity Biotech | CLARK LABORATORIES, INC. |