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 | 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 | 00630414976730 | 10469599 | LRUBCM | Rubella IGG - IMMULITE - CTL | IMMULITE® Systems RUB CONTROL Rubella IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
2 | 00630414976716 | 10469597 | LRMCM | Rubella IGM - IMMULITE - CTL | IMMULITE® Systems RUM CONTROL Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
3 | 00630414971582 | 10374044 | LKRM1(D) | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
4 | 00630414971469 | 10374021 | L2KRM2(D) | Rubella IgM Ab - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems RUM Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
5 | 00630414964614 | 10381292 | LKRUB1 | Rubella IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
6 | 00630414962061 | 10381305 | L2KRUB6 | Rubella IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
7 | 00630414962054 | 10381338 | L2KRUB2 | Rubella IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
8 | 00630414600536 | 10995671 | 10995671 | Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL | Atellica IM Rub G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414600529 | 10995670 | 10995670 | Rubella IgG (Rub G) Atellica IM - RGT 100T | Atellica IM Rub G | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414599847 | 10995669 | 10995669 | Rubella IgM (Rub M) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL | Atellica IM Rub M QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414599830 | 10995668 | 10995668 | Rubella IgM (Rub M) Atellica IM - RGT 50T | Atellica IM Rub M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00630414201443 | 10310286 | 117734 | Rubella IgM - CENTAUR - CONS - 2x2x2,7mL | ADVIA Centaur® Rub M QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00630414201436 | 10310285 | 117733 | Rubella IgM Ab - CENTAUR - RGT - 50 tests | ADVIA Centaur® Rub M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
14 | 00630414201429 | 10310284 | 117711 | Rubella IgG - CENTAUR - CONS - 3x2x2,7mL | ADVIA Centaur® Rub G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
15 | 00630414201412 | 10310283 | 117710 | Rubella IgG Ab - CENTAUR - RGT - 100 tests | ADVIA Centaur® Rub G | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | B3507203600 | 720-360 | 720-360 | ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-qu ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age. | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION |
17 | 15099590624897 | 34430 | 34430 | The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immuno The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. | Access Rubella IgG | BECKMAN COULTER, INC. |
18 | 15099590624880 | 33435 | 34435 | The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. | Access Rubella IgG Calibrators | BECKMAN COULTER, INC. |
19 | 15099590624873 | 34439 | 34439 | The Access Rubella IgG QC is intended for monitoring the system performance of t The Access Rubella IgG QC is intended for monitoring the system performance of the Access Rubella IgG assay. | Access Rubella IgG QC | BECKMAN COULTER, INC. |
20 | 10859035006245 | 84R2 | Alere Rubella-plus® | ALERE NORTH AMERICA, LLC | ||
21 | 10758750004997 | 8536195 | 8536195 | VITROS Immunodiagnostic Products Rubella IgG Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
22 | 10758750004546 | 8209074 | 8209074 | VITROS Immunodiagnostic Products Rubella IgG Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
23 | 10743816001034 | BSP-171-10-01 | BSP-171-10-01 | BioSign® Rubella card; 10 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
24 | 10743816001027 | BSP-171-35-01 | BSP-171-35-01 | BioSign® Rubella card; 35 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
25 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
26 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
27 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
28 | 05391516746786 | 617134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
29 | 05391516746748 | 616134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
30 | 05391516746533 | 525700 | Substrate Solution (TMB) | Trinity Biotech | CLARK LABORATORIES, INC. | |
31 | 05391516746526 | 915401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
32 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
33 | 05391516743457 | 2325360 | 2325360 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
34 | 05391516743440 | 2325350 | 2325350 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
35 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
36 | 04015630940257 | 07027796190 | 07027796190 | Elecsys Rubella IgM | ROCHE DIAGNOSTICS GMBH | |
37 | 04015630940240 | 07027770190 | 07027770190 | Elecsys Rubella IgG | ROCHE DIAGNOSTICS GMBH | |
38 | 04015630939275 | 4618831160 | 4618831160 | Elecsys Rubella IgM Immunoassay | ROCHE DIAGNOSTICS GMBH | |
39 | 04015630939251 | 4618793160 | 4618793160 | Elecsys Rubella IgG Immunoassay | ROCHE DIAGNOSTICS GMBH | |
40 | 03573026138585 | 30226 | VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS fami VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of IgG antibodies to rubella virus in human serum. | VIDAS® RUB IgG | BIOMERIEUX SA | |
41 | 00850487007395 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
42 | 00850487007388 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
43 | 00850487007074 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
44 | 00850487007067 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
45 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
47 | 00847865010696 | 25174 | 25174 | Rubella IgM EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
48 | 00847865010689 | 25173 | 25173 | Rubella IgG EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
49 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |