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 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
3 | 05391516747127 | 2326001 | 2326001 | Captia™ Measles IgG | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Trinity Biotech |
4 | 05391516747455 | 4384240 | System Verify Dye Test for automated analyzers | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | Trinity Biotech | |
5 | 05391516747486 | 2346581 | 2346581 | Captia Borrelia burgdorferi IgG/IgM | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
6 | 05391516747547 | 40-1013 | 40-1013 | B. burgdorferi Wash Buffer (10x) | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
7 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | LYR | Helicobacter Pylori | 1 | Trinity Biotech |
8 | 05391516747479 | 618739 | Serum Diluent Plus | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech | |
9 | 05391516747240 | A7040 | A7040 | ACE CONTROL-E | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
10 | 05391516747233 | A6040 | A6040 | ACE CONTROL-N | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
11 | 05391516747219 | 800-945 | 800-945 | Captia™ Cytomegalovirus IgM Capture | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech |
12 | 05391516747202 | 2346980 | 2346980 | Captia™ Legionella pneumophila IgG/IgM | MJH | Legionella, Spp., Elisa | 2 | Trinity Biotech |
13 | 05391516747189 | 2346580 | 2346580 | Captia™ Borrelia burgdorferi IgG/IgM | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
14 | 05391516747172 | 2338571 | 2338571 | Captia™ ENA Combined Screen | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech |
15 | 05391516747165 | 2337770 | 2337770 | Captia™ Histone | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | Trinity Biotech |
16 | 05391516747158 | 2328250 | 2328250 | Captia™ Rheumatoid Factor IgM | DHR | System, Test, Rheumatoid Factor | 2 | Trinity Biotech |
17 | 05391516747141 | 2327671 | 2327671 | Captia™ ds/DNA | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | Trinity Biotech |
18 | 05391516747066 | 2325601 | 2325601 | Captia™ Varicella-Zoster Virus (VZV) IgG | GQX | Antiserum, Cf, Varicella-Zoster | 2 | Trinity Biotech |
19 | 05391516747059 | 2325561 | 2325561 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgM | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | Trinity Biotech |
20 | 05391516747042 | 2325501 | 2325501 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgG | GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | Trinity Biotech |
21 | 05391516747035 | 2325461 | 2325461 | Captia™ Herpes Simplex Virus 1 (HSV 1) IgM | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | Trinity Biotech |
22 | 05391516747028 | 2325401 | 2325401 | Captia™ Herpes Simplex Virus 1 (HSV1) IgG | GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | Trinity Biotech |
23 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
24 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech |
25 | 05391516746991 | 2325261 | 2325261 | Captia™ Cytomegalovirus (CMV) IgM | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech |
26 | 05391516746984 | 2325201 | 2325201 | Captia™ Cytomegalovirus (CMV) IgG | GQI | Antiserum, Cf, Cytomegalovirus | 2 | Trinity Biotech |
27 | 05391516746977 | 2325161 | 2325161 | Captia™ Toxoplasma gondii IgM | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech |
28 | 05391516746960 | 2325101 | 2325101 | Captia™ Toxoplasma gondii IgG | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Trinity Biotech |
29 | 05391516746953 | 2325001 | 2325001 | Captia™ EBV EA-D IgG | LSE | Epstein-Barr Virus, Other | 1 | Trinity Biotech |
30 | 05391516746946 | 2324701 | 2324701 | Captia™ EBV VCA P-18 IgG | LSE | Epstein-Barr Virus, Other | 1 | Trinity Biotech |
31 | 05391516746939 | 2323901 | 2323901 | Captia™ HSV 2 Type Specific IgG | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | Trinity Biotech |
32 | 05391516746922 | 2323801 | 2323801 | Captia™ HSV 1 Type Specific IgG | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | Trinity Biotech |
33 | 05391516746908 | 829322 | Wash Buffer Concentrate 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
34 | 05391516746892 | 828882 | Trep-Sure Wash Buffer Concentrate, 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
35 | 05391516746885 | 828322 | Wash Buffer Concentrate 20X | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Trinity Biotech | |
36 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
37 | 05391516746861 | 827882 | Trep-Sure Wash Buffer Concentrate, 20X | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech | |
38 | 05391516746854 | 827402 | Wash Buffer Concentrate Type II, 20X | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech | |
39 | 05391516746533 | 525700 | Substrate Solution (TMB) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
40 | 05391516746526 | 915401 | Stop Solution | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
41 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Trinity Biotech | |
42 | 05391516746496 | 2346600 | 2346600 | Captia™ Herpes Group IgG | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Trinity Biotech |
43 | 05391516746489 | 2326660 | 2326660 | Captia™ Herpes Simplex Virus (HSV) Combined IgM | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Trinity Biotech |
44 | 05391516745147 | 2622471 | 2622471 | Captia™ Malaria EIA | OAX | Plasmodium Spp. Detection Reagents | 2 | Trinity Biotech |
45 | 05391516745130 | 2322471 | 2322471 | CAPTIA™ Malaria EIA | OAX | Plasmodium Spp. Detection Reagents | 2 | Trinity Biotech |
46 | 05391516744836 | 800-960 | 800-960 | CAPTIA™ Syphilis (T. Pallidum)-G | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
47 | 05391516744829 | 800-970 | 800-970 | CAPTIA™Syphilis (T. Pallidum)-G | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
48 | 05391516744065 | B1029-440 | B1029-440 | Bartels ELISA Legionella Urinary Antigen | MJH | Legionella, Spp., Elisa | 2 | Trinity Biotech |
49 | 05391516743952 | 2346200 | 2346200 | Captia™ Chlamydia IgG | LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | Trinity Biotech |
50 | 05391516743945 | 2344800 | 2344800 | Captia Mycoplasma IgG | LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 | Trinity Biotech |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00613745050256 | 800-5025 | 5025 | The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease. | ImmunoDOT Borrelia Test | GENBIO |
2 | 00613745039053 | 800-3905 | 3905 | This serum control contains IgG antibodies specific to Borrelia burgdorferi, the This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System. | ImmunoDOT Borrelia Positive Control | GENBIO |
3 | 00613745031101 | 800-3110 | 3110 | The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the quali The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the qualitative and/or semi-quantitative detection of Borrelia burgdorferi total antibodies (IgG, IgM, and IgA) in serum and is used as an aid in the diagnosis of Lyme disease. | ImmunoWELL Borrelia (Lyme) | GENBIO |
4 | B350GSD1010230 | GSD10-1023 | GSD10-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
5 | B350GSD1010220 | GSD10-1022 | GSD10-1022 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - 10 Pack | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
6 | B350GSD0610190 | GSD06-1019 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit - Bulk | Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
7 | B350GSD0610180 | GSD06-1018 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - Bulk | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
8 | B350GSD0410230 | GSD04-1023 | GSD04-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk Pack | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk | GOLD STANDARD DIAGNOSTICS CORPORATION |
9 | B350GSD0410220 | GSD04-1022 | GSD04-1022 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk Pack | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk | GOLD STANDARD DIAGNOSTICS CORPORATION |
10 | B350GSD0110270 | GSD01-1027 | GSD01-1027 | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
11 | B350GSD0110260 | GSD01-1026 | GSD01-1026 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
12 | B350GSD0110250 | GSD01-1025 | GSD01-1025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
13 | B350GSD0110240 | GSD10-1024 | GSD10-1024 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
14 | B350GSD0110230 | GSD01-1023 | GSD01-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
15 | B350GSD0110220 | GSD01-1022 | GSD01-1022 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
16 | B350GSD0110190 | GSD01-1019 | GSD01-1019 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
17 | B350GSD0110180 | GSD01-1018 | GSD01-1018 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
18 | B110BBN61100 | BBN-6110 | BBN-6110 | Borrelia Negative Control | BION ENTERPRISES, LTD. | |
19 | B110BBM61300 | BBM-6130 | BBM-6130 | Borrelia IgM Control | BION ENTERPRISES, LTD. | |
20 | B110BBG61200 | BBG-6120 | BBG-6120 | Borrelia IgG Control | BION ENTERPRISES, LTD. | |
21 | 30014613337799 | 20319 | 20319 | Sofia2 Lyme WB 25T, US | Sofia | QUIDEL CORPORATION |
22 | 30014613202981 | 20298 | 20298 | Sofia Lyme FIA | Sofia | QUIDEL CORPORATION |
23 | 05391516748902 | 32-5001 | 32-5001 | Lyme Negative Control, 250 uL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
24 | 05391516748742 | 44-2020M | 44-2020M | EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM An EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
25 | 05391516748735 | 44-2020GV | 44-2020GV | EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of I EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
26 | 05391516747974 | 40-5065M/B-A | 40-5065M/B-A | B. burgdorferi (IgM) Marblot Strip Test System, 400 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
27 | 05391516747967 | 40-5065G/B-A | 40-5065G/B-A | B. burgdorferi (IgG) Marblot Strip Test System (400 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
28 | 05391516747943 | 90-1610 | 90-1610 | FITC Mounting Medium (pH 7.5), 3.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
29 | 05391516747929 | 90-1700 | 90-1700 | Coverslips, 70x22 mm, 12 each | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
30 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
31 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
32 | 05391516747714 | 40-1006 | 40-1006 | EIA Color Developer, 13.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
33 | 05391516747707 | 44-5017 | 44-5017 | Alkaline Phosphatase Developing Solution, 110mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
34 | 05391516747691 | 40-2525M | 40-2525M | Alkaline Phosphatase Conjugate, Anti-Human IgM, 11 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
35 | 05391516747684 | 40-2029L | 40-2029L | B. burgdorferi WB Weakly Reactive IgM Control,120µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
36 | 05391516747677 | 40-2022L | 40-2022L | B. burgdorferi WB IgM Serum Band Locator, 250µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
37 | 05391516747660 | 40-2525G | 40-2525G | Alkaline Phosphatase Conjugate, Anti-Human IgG, 11mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
38 | 05391516747653 | 40-2019C | 40-2019C | 10x Sample Diluent/Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
39 | 05391516747646 | 40-2017 | 40-2017 | Alkaline Phosphatase Developing Solution, 45mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
40 | 05391516747639 | 40-2027L | 40-2027L | 40-2027L B. burgdorferi WB Weakly Reactive IgG Control, 120µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
41 | 05391516747622 | 40-2023L | 40-2023L | B. burgdorferi WB IgG Serum Band Locator, 250µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
42 | 05391516747615 | 40-2021L | 40-2021L | B. burgdorferi WB Negative Control, 120µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
43 | 05391516747608 | 32-5010 | 32-5010 | B. burgdorferi 10 Well Slides, 10 each pack | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
44 | 05391516747585 | 90-1607 | 90-1607 | Phosphate Buffered Saline, 10g | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
45 | 05391516747547 | 40-1013 | 40-1013 | B. burgdorferi Wash Buffer (10x) | Trinity Biotech | CLARK LABORATORIES, INC. |
46 | 05391516747486 | 2346581 | 2346581 | Captia Borrelia burgdorferi IgG/IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
47 | 05391516747189 | 2346580 | 2346580 | Captia™ Borrelia burgdorferi IgG/IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
48 | 05391516747134 | 41-9002 | B. burgdorferi Marsorb | Trinity Biotech | CLARK LABORATORIES, INC. | |
49 | 05391516746816 | 617474 | Serum Diluent V, Lyme | Trinity Biotech | CLARK LABORATORIES, INC. | |
50 | 05391516746779 | 616474 | Serum Diluent Type V, Lyme | Trinity Biotech | CLARK LABORATORIES, INC. |