| 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 | 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 | 04260157080034 | ORG506 | ORG506 | ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUT ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS (ena) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGONSTIC USE ONLY. | ENASCREEN | ORGENTEC DIAGNOSTIKA GMBH |
| 2 | 04250289502924 | 7102US | 7102US | AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitativ AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6S | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 3 | 04250289500449 | 3102 | AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitativ AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6S | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 4 | 04049016124917 | DL 1590-6401-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 5 | 04049016124900 | DL 1590-1601-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 6 | 04049016086017 | EA 1590-9601-9 G | Anti-ENA Pool ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 7 | 04049016084785 | DL 1590-6401-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 8 | 04049016083139 | DL 1590-1601-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 9 | 04049016027232 | EA 1661-9601 G | Anti-Jo-1 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 10 | 04049016027058 | EA 1599-9601 G | Anti-Scl-70 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 11 | 04049016027041 | EA 1597-9601 G | Anti-SS-B ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 12 | 04049016027034 | EA 1595-9601 G | Anti-SS-A ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 13 | 04048474035711 | EIA-3571 | EIA-3571 | ENA Screen ELISA is a test system for the qualitative screening of IgG class aut ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma .samples. | ENA Screen ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 14 | 00850487007630 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
| 15 | 00850487007623 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
| 16 | 00850487007487 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
| 17 | 00850487007258 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
| 18 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 19 | 00847865002721 | SW4_V2 | 6651160G | Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 20 | 00847865002448 | SW4_V2 | 6651170C | ANA Screen with MDSS Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 21 | 00847865001342 | SW4.1_V2 | 6651160H | Manual & CDs, ANA Screen with MDSS IFU, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 22 | 00847865000093 | 6651155 | 6651155 | ANA Screen with MDSS Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 23 | 00847865000086 | 6651150 | 6651150 | ANA Screen with MDSS Reagent pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 24 | 00847817022425 | 96SB | 96SB | Autoimmune EIA Anti-SS-B/La Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
| 25 | 00847817022418 | 96SA | 96SA | Autoimmune EIA Anti-SS-A/Ro Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
| 26 | 00847817022388 | 96EP | 96EP | Autoimmune EIA ENA Plus Screening test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
| 27 | 00847817022340 | 96CE | 96CE | Autoimmune EIA Anti-Centromere Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
| 28 | 00847817006944 | 220HSP | 220HSP | Autoimmune EIA ENA Conjugate, 15 mL | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
| 29 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 30 | 00845714002960 | 5308 | 5308 | Serum Diluent | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 31 | 00845714002922 | 2514 | 2514 | TMB Substrate | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 32 | 00845714002786 | 2316 | 2316 | Stop Solution | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 33 | 00845714002311 | 5150 | 5150 | Sci-70 Antibody Elisa | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 34 | 00845714002267 | 5129 | 5129 | SS-B (La) Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 35 | 00845714002243 | 5127 | 5127 | Sm Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 36 | 00845714002236 | 5126 | 5126 | RNP Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 37 | 00817273020129 | 720-290 | "720-290 anti-Jo-1 Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 38 | 00817273020112 | 720-280 | "720-280 anti-Scl-70 Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 39 | 00817273020105 | 720-270 | "720-270 anti-SM/RNP Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 40 | 00817273020099 | 72-260 | 720-260 anti-SSB Test Kit | Diamedix | DIAMEDIX CORPORATION | |
| 41 | 00817273020082 | 720-250 | 720-250 anti-SSA Test Kit | Diamedix | DIAMEDIX CORPORATION | |
| 42 | 00817273020075 | 720-240 | 720-240 anti-SM Test Kit | Diamedix | DIAMEDIX CORPORATION | |
| 43 | 00817273020068 | 720-230 | 720-230 ENA-6 Screen Test Kit | Diamedix | DIAMEDIX CORPORATION | |
| 44 | 00817273020051 | 720-130 | 720-130 H.pylori IgG Test Kit | Diamedix | DIAMEDIX CORPORATION | |
| 45 | 00817273020044 | 300-371A | "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 46 | 00816879020380 | FGA38 | 96 well ELISA for the detection of ENA antibodies in human serum | Autostat II Anti-ENA-6 Profile | HYCOR BIOMEDICAL LLC | |
| 47 | 00816879020342 | FGA34 | 96 well ELISA for the detection of anti-Scl-70 antibodies in human serum | Autostat II Anti-Scl-70 | HYCOR BIOMEDICAL LLC | |
| 48 | 00816879020335 | FGA33 | 96 well ELISA for the detection of Anti-Jo-1 antibodies in human serum | Autostat II Anti-Jo-1 | HYCOR BIOMEDICAL LLC | |
| 49 | 00816879020304 | FGA30 | 96 well ELISA for the detection of Anti-SS-B/La antibodies in human serum | Autostat II Anti-SS-B/La | HYCOR BIOMEDICAL LLC | |
| 50 | 00816879020298 | FGA29 | 96 well ELISA for the detection of Anti-SS-A/Ro antibodies in human serum | Autostat II Anti-SS-A/Ro | HYCOR BIOMEDICAL LLC |