No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05391516747226 | 916401 | Stop Solution | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
2 | 05391516747134 | 41-9002 | B. burgdorferi Marsorb | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech | |
3 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
4 | 05391516747127 | 2326001 | 2326001 | Captia™ Measles IgG | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Trinity Biotech |
5 | 05391516747455 | 4384240 | System Verify Dye Test for automated analyzers | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | Trinity Biotech | |
6 | 05391516747486 | 2346581 | 2346581 | Captia Borrelia burgdorferi IgG/IgM | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
7 | 05391516747547 | 40-1013 | 40-1013 | B. burgdorferi Wash Buffer (10x) | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
8 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | LYR | Helicobacter Pylori | 1 | Trinity Biotech |
9 | 05391516747479 | 618739 | Serum Diluent Plus | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech | |
10 | 05391516747240 | A7040 | A7040 | ACE CONTROL-E | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
11 | 05391516747233 | A6040 | A6040 | ACE CONTROL-N | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
12 | 05391516747219 | 800-945 | 800-945 | Captia™ Cytomegalovirus IgM Capture | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech |
13 | 05391516747202 | 2346980 | 2346980 | Captia™ Legionella pneumophila IgG/IgM | MJH | Legionella, Spp., Elisa | 2 | Trinity Biotech |
14 | 05391516747189 | 2346580 | 2346580 | Captia™ Borrelia burgdorferi IgG/IgM | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
15 | 05391516747172 | 2338571 | 2338571 | Captia™ ENA Combined Screen | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech |
16 | 05391516747165 | 2337770 | 2337770 | Captia™ Histone | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | Trinity Biotech |
17 | 05391516747158 | 2328250 | 2328250 | Captia™ Rheumatoid Factor IgM | DHR | System, Test, Rheumatoid Factor | 2 | Trinity Biotech |
18 | 05391516747141 | 2327671 | 2327671 | Captia™ ds/DNA | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | Trinity Biotech |
19 | 05391516747066 | 2325601 | 2325601 | Captia™ Varicella-Zoster Virus (VZV) IgG | GQX | Antiserum, Cf, Varicella-Zoster | 2 | Trinity Biotech |
20 | 05391516747059 | 2325561 | 2325561 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgM | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | Trinity Biotech |
21 | 05391516747042 | 2325501 | 2325501 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgG | GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | Trinity Biotech |
22 | 05391516747035 | 2325461 | 2325461 | Captia™ Herpes Simplex Virus 1 (HSV 1) IgM | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | Trinity Biotech |
23 | 05391516747028 | 2325401 | 2325401 | Captia™ Herpes Simplex Virus 1 (HSV1) IgG | GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | Trinity Biotech |
24 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
25 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
26 | 05391516746991 | 2325261 | 2325261 | Captia™ Cytomegalovirus (CMV) IgM | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech |
27 | 05391516746984 | 2325201 | 2325201 | Captia™ Cytomegalovirus (CMV) IgG | GQI | Antiserum, Cf, Cytomegalovirus | 2 | Trinity Biotech |
28 | 05391516746977 | 2325161 | 2325161 | Captia™ Toxoplasma gondii IgM | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech |
29 | 05391516746960 | 2325101 | 2325101 | Captia™ Toxoplasma gondii IgG | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech |
30 | 05391516746953 | 2325001 | 2325001 | Captia™ EBV EA-D IgG | LSE | Epstein-Barr Virus, Other | 1 | Trinity Biotech |
31 | 05391516746946 | 2324701 | 2324701 | Captia™ EBV VCA P-18 IgG | LSE | Epstein-Barr Virus, Other | 1 | Trinity Biotech |
32 | 05391516746939 | 2323901 | 2323901 | Captia™ HSV 2 Type Specific IgG | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | Trinity Biotech |
33 | 05391516746922 | 2323801 | 2323801 | Captia™ HSV 1 Type Specific IgG | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | Trinity Biotech |
34 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
35 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
36 | 05391516746885 | 828322 | Wash Buffer Concentrate 20X | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech | |
37 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
38 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
39 | 05391516746854 | 827402 | Wash Buffer Concentrate Type II, 20X | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech | |
40 | 05391516746533 | 525700 | Substrate Solution (TMB) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
41 | 05391516746526 | 915401 | Stop Solution | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
42 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
43 | 05391516746496 | 2346600 | 2346600 | Captia™ Herpes Group IgG | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Trinity Biotech |
44 | 05391516746489 | 2326660 | 2326660 | Captia™ Herpes Simplex Virus (HSV) Combined IgM | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Trinity Biotech |
45 | 05391516745147 | 2622471 | 2622471 | Captia™ Malaria EIA | OAX | Plasmodium Spp. Detection Reagents | 2 | Trinity Biotech |
46 | 05391516745130 | 2322471 | 2322471 | CAPTIA™ Malaria EIA | OAX | Plasmodium Spp. Detection Reagents | 2 | Trinity Biotech |
47 | 05391516744836 | 800-960 | 800-960 | CAPTIA™ Syphilis (T. Pallidum)-G | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
48 | 05391516744829 | 800-970 | 800-970 | CAPTIA™Syphilis (T. Pallidum)-G | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
49 | 05391516744065 | B1029-440 | B1029-440 | Bartels ELISA Legionella Urinary Antigen | MJH | Legionella, Spp., Elisa | 2 | Trinity Biotech |
50 | 05391516743952 | 2346200 | 2346200 | Captia™ Chlamydia IgG | LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | Trinity Biotech |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00630414976891 | 10471981 | L2KSY2(D) | Syphilis - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems SYP Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
2 | 00630414976709 | 10469595 | LCVGCM | CMV IgG - IMMULITE - CTL | IMMULITE® Systems CVG CONTROL CMV IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
3 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | IMMULITE® Systems SYP CONTROL Syphilis Screen | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
4 | 00630414599892 | 10995676 | 10995676 | Syphillis (Syph) QC Kit Atellica IM - CLT 2 x 2 x 7.0mL | Atellica IM Syph QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414599885 | 10995675 | 10995675 | Syphillis (Syph) Atellica IM - RGT 200T | Atellica IM Syph | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414580173 | 10492493 | 10492493 | Syphilis - CENTAUR - RGT - 200 tests | ADVIA Centaur® SYPH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 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. | |
8 | 00380740138332 | 07P6031 | 07P6031 | Alinity i Syphilis TP Reagent Kit 1200 Tests | Alinity | ABBOTT GMBH |
9 | 00380740138196 | 07P6021 | 07P6021 | Alinity i Syphilis TP Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
10 | 00380740117122 | 8D06-41 | 08D0641 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
11 | 00380740117115 | 8D06-31 | 08D0631 | ARCHITECT Syphilis TP Reagent Kit | ARCHITECT | ABBOTT GMBH |
12 | 00380740103545 | 8D06-13 | 08D0613 | ARCHITECT Syphilis TP Controls | ARCHITECT | ABBOTT GMBH |
13 | 00380740103538 | 8D06-04 | 08D0604 | ARCHITECT Syphilis TP Calibrator | ARCHITECT | ABBOTT GMBH |
14 | 07613336171998 | 09015051190 | 09015051190 | Syphilis Elecsys E2G 300 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
15 | 07613336171950 | 09014977190 | 09014977190 | Syphilis Elecsys cobas e 100 V2 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH |
16 | 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. |
17 | 05391516748759 | 1206710 | 1206710 | Uni-Gold™ Syphilis Treponemal, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
18 | 05391516747462 | TS-96-E | TS-96-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
19 | 05391516747448 | TS-960-E | TS-960-E | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
20 | 05391516747431 | TS-960 | TS-960 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
21 | 05391516747424 | TS-96-Bulk | Trep Sure Bulk Kit | Phoenix Biotech | CLARK LABORATORIES, INC. | |
22 | 05391516747417 | TS-96 | TS-96 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
23 | 05391516747400 | TS-1920 | TS-1920 | Trep-Sure™ | Phoenix Biotech | CLARK LABORATORIES, INC. |
24 | 05391516747226 | 916401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
25 | 05391516746915 | 386470 | 386470 | Trep-Sure Conjugate | Phoenix Biotech | CLARK LABORATORIES, INC. |
26 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
27 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
28 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
29 | 05391516746847 | 525777 | 525777 | Trep-Sure Substrate | Phoenix Biotech | CLARK LABORATORIES, INC. |
30 | 05391516746694 | 72520 | 72520 | Syphilis IgM EIA | BIO-RAD | CLARK LABORATORIES, INC. |
31 | 05391516746687 | 72517 | 72517 | Wash Solution, x20 (Non US Sales Only) | Bio-Rad | CLARK LABORATORIES, INC. |
32 | 05391516746588 | YY60126 | Syphilis EIA (Non-US sales only) | Bio-Stat | CLARK LABORATORIES, INC. | |
33 | 05391516745109 | 2322171 | 2322171 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
34 | 05391516745093 | 2322170 | 2322170 | CAPTIA™ Syphilis TA EIA | Trinity Biotech | CLARK LABORATORIES, INC. |
35 | 05391516745048 | 2329360 | 2329360 | CAPTIA™ NMT Syphilis IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
36 | 05391516744836 | 800-960 | 800-960 | CAPTIA™ Syphilis (T. Pallidum)-G | Trinity Biotech | CLARK LABORATORIES, INC. |
37 | 05391516744829 | 800-970 | 800-970 | CAPTIA™Syphilis (T. Pallidum)-G | Trinity Biotech | CLARK LABORATORIES, INC. |
38 | 04987270235041 | 235041 | Lumipulse G TP-N Immunoreaction Cartridges Set | FUJIREBIO INC. | ||
39 | 04015630940356 | 07251378190 | 07251378190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
40 | 04015630934881 | 06923348190 | 06923348190 | Elecsys Syphilis | ROCHE DIAGNOSTICS GMBH | |
41 | 03610522015597 | 12007240 | 12007240 | U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
42 | 03610522004980 | 12006863 | 12006863 | BioPlex 2200 Sample Dilution Buffer (1X), 120 mL | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
43 | 03610520992692 | 4.3 | 12000656 | U.S. IFU, Manual & CDs, BioPlex 2200 Syphilis Total & RPR SW4.3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
44 | 03610520653012 | 12000650 | 12000650 | BioPlex 2200 Syphilis Total & RPR Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
45 | 03610520138267 | 4.3_v1 | 12000657 | BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 00868926000302 | B012 | Syphilis Health Check | VEDALAB | ||
47 | 00850487007609 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
48 | 00850487007043 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
49 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |