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 | 00817273020365 | 720-650 | "720-650 EBV-EA-D IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
12 | 00817273020358 | 720-640 | "720-640 EBV-EA-D IgG Test Kit" | GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | Diamedix | |
13 | 00817273020341 | 720-630 | "720-630 EBNA-1 IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
14 | 00817273020334 | 720-620 | "720-620 EBNA-1 IgG Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
15 | 00817273020327 | 720-610 | "720-610 EBV-VCA IgM Test Kit" | LSE | Epstein-Barr Virus, Other | 1 | Diamedix | |
16 | 00817273020310 | 720-600 | "720-600 EBV-VCA IgG Test Kit" | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | Diamedix | |
17 | 00817273020303 | 720-540 | "720-540 Mumps IgG Test Kit" | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Diamedix | |
18 | 00817273020297 | 720-520 | "720-520 Measles IgG Test Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
19 | 00817273020280 | 720-480 | "720-480 anti-Cardiolipin Screen" | JZO | System, Test, Thyroid Autoantibody | 2 | Diamedix | |
20 | 00817273020273 | 720-460 | "720-460 anti-TG IgG Test Kit" | JZO | System, Test, Thyroid Autoantibody | 2 | Diamedix | |
21 | 00817273020266 | 720-450 | "720-450 anti-TPO IgG Test Kit" | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | Diamedix | |
22 | 00817273020259 | 720-440 | "720-440 anti-PR-3 (C-ANCA) IgG Test Kit" | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | Diamedix | |
23 | 00817273020242 | 720-430 | "720-430 anti-MPO (P-ANCA) IgG Test Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
24 | 00817273020235 | 720-420 | "720-420 anti-Cardiolipin IgATest Kit" | MID | System, Test, Anticardiolipin Immunological | 2 | Diamedix | |
25 | 00817273020228 | 720-400 | "720-400 anti-Cardiolipin IgG/IgM Test Kit" | LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 2 | Diamedix | |
26 | 00817273020211 | 720-380 | "720-380 VZV IgG Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
27 | 00817273020204 | 720-370 | "720-370 Rubella IgM Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
28 | 00817273020198 | 720-360 | "720-360 Rubella IgG Test Kit" | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Diamedix | |
29 | 00817273020181 | 720-350 | "720-350 HSV 1&2 IgM Test Kit" | LCG | Intestinal Splinting Tubes | 2 | Diamedix | |
30 | 00817273020174 | 720-340 | "720-340 HSV 1&2 IgG Test Kit" | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Diamedix | |
31 | 00817273020167 | 720-330 | "720-330 CMV IgM Test Kit" | LJO | Antigen, Iha, Cytomegalovirus | 2 | Diamedix | |
32 | 00817273020150 | 720-320 | "720-320 CMV IgG Test Kit" | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Diamedix | |
33 | 00817273020143 | 720-310 | "720-310 Toxoplasma IgM Test Kit" | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix | |
34 | 00817273020136 | 720-300 | "720-300 Toxoplasma IgG Test Kit" | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Diamedix | |
35 | 00817273020129 | 720-290 | "720-290 anti-Jo-1 Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
36 | 00817273020112 | 720-280 | "720-280 anti-Scl-70 Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
37 | 00817273020105 | 720-270 | "720-270 anti-SM/RNP Test Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
38 | 00817273020099 | 72-260 | 720-260 anti-SSB 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 | 08426950593478 | 704615 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. C1q Coated Wells: 12 breakapart 8 well strips coated with human C1q. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. C1q CIC Calibrators: 5 bottles, each containing 1.2mL of diluted aggregated human IgG, with the following concentrations of immune complex: 100, 33.3, 11.1, 3.7, 1.23 µg Eq/mL. Ready to use.6. C1q CIC Positive Control: 1 bottle containing 1.2mL of diluted aggregated human IgG. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 9. HRP C1q CIC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10.TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. | QUANTA Lite® HA dsDNA ELISA | INOVA DIAGNOSTICS, INC. | |
2 | 08426950544111 | 704650 | 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating t 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use.6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. | QUANTA Lite® dsDNA SC ELISA | INOVA DIAGNOSTICS, INC. | |
3 | 05391516747141 | 2327671 | 2327671 | Captia™ ds/DNA | Trinity Biotech | CLARK LABORATORIES, INC. |
4 | 05391516743723 | 2327670 | 2327670 | Captia™ dsDNA | Trinity Biotech | CLARK LABORATORIES, INC. |
5 | 04260157080683 | ORG604 | ORG604 | Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. This product is intended for professional in vitro diagnostic use only. | ANTI-dsDNA | ORGENTEC DIAGNOSTIKA GMBH |
6 | 04049016026884 | EA 1572-9601 G | Anti-dsDNA-NcX ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
7 | 04048474035667 | EIA-3566 | EIA-3566 | Anti-dsDNA Screen ELISA is a test system for the quantitative measurement of IgG Anti-dsDNA Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against double-stranded DNA (dsDNA) in human serum or plasma. | Anti-dsDNA Screen ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
8 | 04048474035650 | EIA-3565 | EIA-3565 | Anti-dsDNA IgA ELISA is a test system for the quantitative measurement of IgA cl Anti-dsDNA IgA ELISA is a test system for the quantitative measurement of IgA class autoantibodies against double-stranded DNA in human serum or plasma. | Anti-dsDNA IgA ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
9 | 04048474035643 | EIA-3564 | EIA-3564 | Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM cl Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodies against double-stranded DNA (dsDNA) in human serum or plasma. | Anti-dsDNA IgM ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
10 | 04048474034387 | EIA-3438 | EIA-3438 | Anti-dsDNA IgG ELISA is a test system for the quantitative measurement of IgG cl Anti-dsDNA IgG ELISA is a test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. | Anti-dsDNA IgG ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
11 | 00855360006205 | 13086 | 13086 | INTENDED USEAnti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for INTENDED USEAnti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG classautoantibodies against double-stranded DNA in human serum or plasma. The assay is intended as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAutoimmune diseases are characterized by the occurence of antibodies against one’s own antigenic structures, also known as autoantibodies. Presence of autoantibodies to native desoxyribonucleic acids (n-DNA, dsDNA, double-stranded DNA) is typical for the clinical picture of SLE. Antibodies against dsDNA belong to the group of Anti Nuclear Antibodies (ANA), which are directed against various structures of the nucleus of the cell. They appear in a variety of rheumatoid diseases. Antibodies to dsDNA are found during the active phases of SLE. Diagnostic sensitivity of the anti-dsDNA determination in cases of SLE is approximately 91 % combined with a diagnostic specificity of nearly 96 percent. SLE like diseases are caused by some drugs. For differential diagnosis of drug-induced SLE the determination of anti-dsDNA is a valuable diagnostic tool. PRINCIPLE OF THE TESTHuman recombinant double-stranded DNA (dsDNA) is bound to microwells. Antibodies to this antigen bind to the respective antigen. Washing of the microwells removes unspecific serum/plasma components. Horseradish peroxidase (HRP) conjugated anti-human IgG immunologically detects the bound patient antibodies forming a conjugate/antibody/antigen complex. Washing of the microwells removes unbound conjugate. An enzyme substrate in the presence of bound conjugate hydrolyzes to form a blue color. The addition of an acid stops the reaction forming a yellow color in the test well which is measured photometrically at 450 nm. The amount of color is directly proportional to the concentration of IgG antibodies present in the original sample. Refer to Product Package Insert. | REAADS Anti-dsDNA Test Kit | CORGENIX MEDICAL CORPORATION |
12 | 00850487007449 | Anti-dsDNA | Q01-210 | Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
13 | 00850487007289 | Anti-dsDNA | Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. | |
14 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
15 | 00847865002721 | SW4_V2 | 6651160G | Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
16 | 00847865002448 | SW4_V2 | 6651170C | ANA Screen with MDSS Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
17 | 00847865001342 | SW4.1_V2 | 6651160H | Manual & CDs, ANA Screen with MDSS IFU, SW4.1_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
18 | 00847865000093 | 6651155 | 6651155 | ANA Screen with MDSS Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
19 | 00847865000086 | 6651150 | 6651150 | ANA Screen with MDSS Reagent pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
20 | 00847817022463 | 96SS | 96SS | Autoimmune EIA Anti-ssDNA Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
21 | 00847817022364 | 96DS | 96DS | Autoimmune EIA Anti-dsDNA Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
22 | 00847817007040 | 240DW | 240DW | Autoimmune EIA DNA Wash Concentrate, 60 mL | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
23 | 00847817007033 | 240DD | 240DD | Autoimmune EIA DNA Sample Diluent, 30 mL | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
24 | 00847817006937 | 220HDS | 220HDS | Autoimmune EIA DNA Conjugate, 15 mL | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
25 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
26 | 00845714002960 | 5308 | 5308 | Serum Diluent | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
27 | 00845714002922 | 2514 | 2514 | TMB Substrate | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
28 | 00845714002786 | 2316 | 2316 | Stop Solution | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
29 | 00845714001888 | 5120 | 5120 | dsDNA Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
30 | 00817273020372 | 720-700 | "720-700 anti-dsDNA Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
31 | 00816879020014 | FGA01 | 96 well ELISA for the detection of anti-dsDNA antibodies in human serum | Autostat II Anti-ds-DNA | HYCOR BIOMEDICAL LLC |