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 | 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 | 05391516748902 | 32-5001 | 32-5001 | Lyme Negative Control, 250 uL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
2 | 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. |
3 | 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. |
4 | 05391516747974 | 40-5065M/B-A | 40-5065M/B-A | B. burgdorferi (IgM) Marblot Strip Test System, 400 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
5 | 05391516747967 | 40-5065G/B-A | 40-5065G/B-A | B. burgdorferi (IgG) Marblot Strip Test System (400 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
6 | 05391516747943 | 90-1610 | 90-1610 | FITC Mounting Medium (pH 7.5), 3.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
7 | 05391516747929 | 90-1700 | 90-1700 | Coverslips, 70x22 mm, 12 each | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
8 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
9 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
10 | 05391516747714 | 40-1006 | 40-1006 | EIA Color Developer, 13.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
11 | 05391516747707 | 44-5017 | 44-5017 | Alkaline Phosphatase Developing Solution, 110mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
12 | 05391516747691 | 40-2525M | 40-2525M | Alkaline Phosphatase Conjugate, Anti-Human IgM, 11 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
13 | 05391516747684 | 40-2029L | 40-2029L | B. burgdorferi WB Weakly Reactive IgM Control,120µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
14 | 05391516747677 | 40-2022L | 40-2022L | B. burgdorferi WB IgM Serum Band Locator, 250µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
15 | 05391516747660 | 40-2525G | 40-2525G | Alkaline Phosphatase Conjugate, Anti-Human IgG, 11mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
16 | 05391516747653 | 40-2019C | 40-2019C | 10x Sample Diluent/Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
17 | 05391516747646 | 40-2017 | 40-2017 | Alkaline Phosphatase Developing Solution, 45mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
18 | 05391516747639 | 40-2027L | 40-2027L | 40-2027L B. burgdorferi WB Weakly Reactive IgG Control, 120µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
19 | 05391516747622 | 40-2023L | 40-2023L | B. burgdorferi WB IgG Serum Band Locator, 250µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
20 | 05391516747615 | 40-2021L | 40-2021L | B. burgdorferi WB Negative Control, 120µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
21 | 05391516747608 | 32-5010 | 32-5010 | B. burgdorferi 10 Well Slides, 10 each pack | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
22 | 05391516747585 | 90-1607 | 90-1607 | Phosphate Buffered Saline, 10g | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
23 | 05391516747547 | 40-1013 | 40-1013 | B. burgdorferi Wash Buffer (10x) | Trinity Biotech | CLARK LABORATORIES, INC. |
24 | 05391516747486 | 2346581 | 2346581 | Captia Borrelia burgdorferi IgG/IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
25 | 05391516747189 | 2346580 | 2346580 | Captia™ Borrelia burgdorferi IgG/IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
26 | 05391516747134 | 41-9002 | B. burgdorferi Marsorb | Trinity Biotech | CLARK LABORATORIES, INC. | |
27 | 05391516746816 | 617474 | Serum Diluent V, Lyme | Trinity Biotech | CLARK LABORATORIES, INC. | |
28 | 05391516746779 | 616474 | Serum Diluent Type V, Lyme | Trinity Biotech | CLARK LABORATORIES, INC. | |
29 | 05391516746649 | 40-8696M/J | 40-8696M/J | Borrelia burgdorferi EIA IgM | MarDx | CLARK LABORATORIES, INC. |
30 | 05391516746632 | 40-8696M | 40-8696M | Borrelia burgdorferi EIA IgM | MarDx | CLARK LABORATORIES, INC. |
31 | 05391516746625 | 40-8696G | 40-8696G | Borrelia burgdorferi EIA IgG | MarDx | CLARK LABORATORIES, INC. |
32 | 05391516746618 | 40-8696P/J | 40-8696P/J | Borrelia burgdorferi EIA IgG + IgM | MarDx | CLARK LABORATORIES, INC. |
33 | 05391516746601 | 40-8696P | 40-8696P | Borrelia burgdorferi EIA IgG + IgM | MarDx | CLARK LABORATORIES, INC. |
34 | 05391516746380 | 32-5003 | 32-5003 | Lyme IgM Positive Control, 250 uL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
35 | 05391516746373 | 32-5002 | 32-5002 | Lyme IgG Positive Control, 250 uL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
36 | 05391516746304 | 40-8696P/J | 40-8696P/J | B. burgdorferi EIA (IgG, IgM) Test System (480 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
37 | 05391516746298 | 40-8696P | 40-8696P | B. burgdorferi EIA (IgG, IgM) Test System (96 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
38 | 05391516746281 | 40-8696M/J | 40-8696M/J | B. burgdorferi EIA (IgM) Test System (480 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
39 | 05391516746274 | 40-8696M | 40-8696M | B. burgdorferi EIA (IgM) Test System (96 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
40 | 05391516746267 | 40-8696G | 40-8696G | B. burgdorferi EIA (IgG) Test System (96 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
41 | 05391516746250 | 40-5065M/B | 40-5065M/B | B. burgdorferi (IgM) Marblot Strip Test System (400 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
42 | 05391516746243 | 40-5065M | 40-5065M | B. burgdorferi (IgM) Marblot Strip Test System (50 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
43 | 05391516746236 | 40-5065G/B | 40-5065G/B | B. burgdorferi (IgG) Marblot Strip Test System (400 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
44 | 05391516746229 | 40-5065G | 40-5065G | B. burgdorferi (IgG) Marblot Strip Test System (50 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
45 | 05391516746212 | 40-2075M | 40-2075M | B. burgdorferi (IgM) Marblot Strip Test System (20 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
46 | 05391516746205 | 40-2075G | 40-2075G | B. burgdorferi (IgG) Marblot Strip Test System (20 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
47 | 05391516746199 | 32-5100M | 32-5100M | Lyme Disease IgM IFA Test System (100 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
48 | 05391516746182 | 32-5100G | 32-5100G | Lyme Disease IgG IFA Test System (100 Tests) | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
49 | EVIRBBSMUS1 | V-BBSMUS | V-BBSMUS | Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum. | Borrelia B31 IgM ViraStripe® Test Kit | VIRAMED BIOTECH AG |
50 | EVIRBBSMPS1 | V-BBSMPS | V-BBSMPS | Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum. | Borrelia B31 IgM ViraStripe® Deca Kit plus | VIRAMED BIOTECH AG |