No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817273020471 | MAGO 4S | Mago 4S Anayzer | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | Diamedix | |
2 | 00817273020464 | MAGO Plus | MAGO Plus chemistry analyzer | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | Diamedix | |
3 | 00817273020457 | 789-009 | "789-009 EZ Complement High Control" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
4 | 00817273020440 | 789-008 | "789-008 EZ Complement Low Control" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
5 | 00817273020433 | 789-006 | "789-006 EZ Complement Reference Serum" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
6 | 00817273020426 | 789-001 | "789-001 EZ Complement Cells" | DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | Diamedix | |
7 | 00817273020419 | 720-850 | "720-850 Mycoplasma IgG Test Kit" | LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 | Diamedix | |
8 | 00817273020402 | 720-830 | "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | Diamedix | |
9 | 00817273020396 | 720-790 | "720-790 ANA ELISA Screen Test Kit" | LKJ | Antinuclear Antibody, Antigen, Control | 2 | Diamedix | |
10 | 00817273020389 | 720-710 | "720-710 Rheumatoid Factor Test Kit" | DHR | System, Test, Rheumatoid Factor | 2 | Diamedix | |
11 | 00817273020372 | 720-700 | "720-700 anti-dsDNA Test Kit" | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | Diamedix | |
12 | 00817273020365 | 720-650 | "720-650 EBV-EA-D IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
13 | 00817273020358 | 720-640 | "720-640 EBV-EA-D IgG Test Kit" | GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | Diamedix | |
14 | 00817273020341 | 720-630 | "720-630 EBNA-1 IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
15 | 00817273020334 | 720-620 | "720-620 EBNA-1 IgG Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
16 | 00817273020327 | 720-610 | "720-610 EBV-VCA IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
17 | 00817273020310 | 720-600 | "720-600 EBV-VCA IgG Test Kit" | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | Diamedix | |
18 | 00817273020303 | 720-540 | "720-540 Mumps IgG Test Kit" | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Diamedix | |
19 | 00817273020297 | 720-520 | "720-520 Measles IgG Test Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
20 | 00817273020280 | 720-480 | "720-480 anti-Cardiolipin Screen" | JZO | System, Test, Thyroid Autoantibody | 2 | Diamedix | |
21 | 00817273020273 | 720-460 | "720-460 anti-TG IgG Test Kit" | JZO | System, Test, Thyroid Autoantibody | 2 | Diamedix | |
22 | 00817273020266 | 720-450 | "720-450 anti-TPO IgG Test Kit" | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | Diamedix | |
23 | 00817273020259 | 720-440 | "720-440 anti-PR-3 (C-ANCA) IgG Test Kit" | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | Diamedix | |
24 | 00817273020242 | 720-430 | "720-430 anti-MPO (P-ANCA) IgG Test Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
25 | 00817273020235 | 720-420 | "720-420 anti-Cardiolipin IgATest Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
26 | 00817273020228 | 720-400 | "720-400 anti-Cardiolipin IgG/IgM Test Kit" | LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 2 | Diamedix | |
27 | 00817273020211 | 720-380 | "720-380 VZV IgG Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
28 | 00817273020204 | 720-370 | "720-370 Rubella IgM Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
29 | 00817273020198 | 720-360 | "720-360 Rubella IgG Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
30 | 00817273020181 | 720-350 | "720-350 HSV 1&2 IgM Test Kit" | LCG | Intestinal Splinting Tubes | 2 | Diamedix | |
31 | 00817273020174 | 720-340 | "720-340 HSV 1&2 IgG Test Kit" | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Diamedix | |
32 | 00817273020167 | 720-330 | "720-330 CMV IgM Test Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
33 | 00817273020150 | 720-320 | "720-320 CMV IgG Test Kit" | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Diamedix | |
34 | 00817273020143 | 720-310 | "720-310 Toxoplasma IgM Test Kit" | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix | |
35 | 00817273020136 | 720-300 | "720-300 Toxoplasma IgG Test Kit" | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix | |
36 | 00817273020129 | 720-290 | "720-290 anti-Jo-1 Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
37 | 00817273020112 | 720-280 | "720-280 anti-Scl-70 Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
38 | 00817273020105 | 720-270 | "720-270 anti-SM/RNP Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
39 | 00817273020082 | 720-250 | 720-250 anti-SSA Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
40 | 00817273020075 | 720-240 | 720-240 anti-SM Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
41 | 00817273020068 | 720-230 | 720-230 ENA-6 Screen Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
42 | 00817273020051 | 720-130 | 720-130 H.pylori IgG Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
43 | 00817273020044 | 300-371A | "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
44 | 00817273020037 | 300-331A | 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit | LYR | Helicobacter Pylori | 1 | Diamedix | |
45 | 00817273020020 | 300-312A | "300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
46 | 00817273020013 | 251-035 | 251-035 ProbeClean Concentration Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
47 | 00817273020006 | 250-030 | Calibration Test Kit | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05391516749169 | 40-3022L | 40-3022L | HEp-2 WB IgG Positive Control, 250 µL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
2 | 05391516747851 | 40-3025G | 40-3025G | Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
3 | 05391516747844 | 40-3020G | 40-3020G | HEp-2 Marblot Strip Test System, Western Blot System for the detection of IgG an HEp-2 Marblot Strip Test System, Western Blot System for the detection of IgG antibody to human extractable nuclear antigens, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
4 | 05391516747646 | 40-2017 | 40-2017 | Alkaline Phosphatase Developing Solution, 45mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
5 | 05391516747172 | 2338571 | 2338571 | Captia™ ENA Combined Screen | Trinity Biotech | CLARK LABORATORIES, INC. |
6 | 05391516746854 | 827402 | Wash Buffer Concentrate Type II, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
7 | 05391516746809 | 617434 | Serum Diluent Type III | Trinity Biotech | CLARK LABORATORIES, INC. | |
8 | 05391516746762 | 616434 | Serum Diluent III | Trinity Biotech | CLARK LABORATORIES, INC. | |
9 | 05391516743860 | 2338570 | 2338570 | Captia™ ENA Combined Screen | Trinity Biotech | CLARK LABORATORIES, INC. |
10 | 05391516743822 | 2338170 | 2338170 | Captia™ ENA Profile | Trinity Biotech | CLARK LABORATORIES, INC. |
11 | 05391516743792 | 2337570 | 2337570 | Captia™ Jo-1 | Trinity Biotech | CLARK LABORATORIES, INC. |
12 | 05391516743785 | 2337470 | 2337470 | Captia™ Scl-70 | Trinity Biotech | CLARK LABORATORIES, INC. |
13 | 05391516743754 | 2337170 | 2337170 | Captia™ SSB (La) | Trinity Biotech | CLARK LABORATORIES, INC. |
14 | 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 |
15 | 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 |
16 | 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 | |
17 | 04049016124917 | DL 1590-6401-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
18 | 04049016124900 | DL 1590-1601-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
19 | 04049016086017 | EA 1590-9601-9 G | Anti-ENA Pool ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
20 | 04049016084785 | DL 1590-6401-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
21 | 04049016083139 | DL 1590-1601-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
22 | 04049016027232 | EA 1661-9601 G | Anti-Jo-1 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
23 | 04049016027058 | EA 1599-9601 G | Anti-Scl-70 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
24 | 04049016027041 | EA 1597-9601 G | Anti-SS-B ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
25 | 04049016027034 | EA 1595-9601 G | Anti-SS-A ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
26 | 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 |
27 | 00850487007630 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
28 | 00850487007623 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
29 | 00850487007487 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
30 | 00850487007258 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
31 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
32 | 00847865002721 | SW4_V2 | 6651160G | Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
33 | 00847865002448 | SW4_V2 | 6651170C | ANA Screen with MDSS Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
34 | 00847865001342 | SW4.1_V2 | 6651160H | Manual & CDs, ANA Screen with MDSS IFU, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
35 | 00847865000093 | 6651155 | 6651155 | ANA Screen with MDSS Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
36 | 00847865000086 | 6651150 | 6651150 | ANA Screen with MDSS Reagent pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
37 | 00847817022425 | 96SB | 96SB | Autoimmune EIA Anti-SS-B/La Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
38 | 00847817022418 | 96SA | 96SA | Autoimmune EIA Anti-SS-A/Ro Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
39 | 00847817022388 | 96EP | 96EP | Autoimmune EIA ENA Plus Screening test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
40 | 00847817022340 | 96CE | 96CE | Autoimmune EIA Anti-Centromere Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
41 | 00847817006944 | 220HSP | 220HSP | Autoimmune EIA ENA Conjugate, 15 mL | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
42 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
43 | 00845714002960 | 5308 | 5308 | Serum Diluent | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
44 | 00845714002922 | 2514 | 2514 | TMB Substrate | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
45 | 00845714002786 | 2316 | 2316 | Stop Solution | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
46 | 00845714002311 | 5150 | 5150 | Sci-70 Antibody Elisa | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
47 | 00845714002267 | 5129 | 5129 | SS-B (La) Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
48 | 00845714002243 | 5127 | 5127 | Sm Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
49 | 00845714002236 | 5126 | 5126 | RNP Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
50 | 00817273020129 | 720-290 | "720-290 anti-Jo-1 Test Kit" | Diamedix | DIAMEDIX CORPORATION |