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 | 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 | 05391516747479 | 618739 | Serum Diluent Plus | Trinity Biotech | CLARK LABORATORIES, INC. | |
2 | 05391516746977 | 2325161 | 2325161 | Captia™ Toxoplasma gondii IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
3 | 05391516746960 | 2325101 | 2325101 | Captia™ Toxoplasma gondii IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
4 | 05391516746823 | 617739 | Serum Diluent Plus | Trinity Biotech | CLARK LABORATORIES, INC. | |
5 | 05391516743396 | 2325160 | 2325160 | Captia™ Toxoplasma gondii IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
6 | 05391516743389 | 2325150 | 2325150 | Captia™ Toxoplasma gondii IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
7 | 05391516743372 | 2325100 | 2325100 | Captia™ Toxoplasma gondii IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
8 | 04015630940318 | 07028024190 | 07028024190 | Elecsys Toxo IgM | ROCHE DIAGNOSTICS GMBH | |
9 | 04015630940301 | 07028008190 | 07028008190 | Elecsys Toxo IgG | ROCHE DIAGNOSTICS GMBH | |
10 | 04015630939336 | 4618815160 | 4618815160 | Elecsys Toxo IgG Immunoassay | ROCHE DIAGNOSTICS GMBH | |
11 | 04015630921485 | 04618858190 | 04618858190 | Elecsys Toxo IgM | ROCHE DIAGNOSTICS GMBH | |
12 | 03610521167488 | 4.3_v1 | 12005791 | U.S. IFU, Manual & CDs, BioPlex 2200 ToRC IgM IFU SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 03610520992715 | 12000670 | 12000670 | BioPlex 2200 ToRC IgM Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 03610520150269 | 4.3_v1 | 12000671 | BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
15 | 03610520007853 | 26211 | 26211 | PLATELIA Toxo IgM | PLATELIA | BIO-RAD |
16 | 03573026263010 | 30222-01 | VIDAS ® TOXO IgG Avidity assay is a qualitative IA intended for use on VIDAS fa VIDAS ® TOXO IgG Avidity assay is a qualitative IA intended for use on VIDAS family instrument for the determination of anti - toxoplasma IgG avidity in human serum. | VIDAS® TOXOIgG AVIDITY | BIOMERIEUX SA | |
17 | 03573026156862 | 30211-01 | VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use o VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use on VIDAS family instrument for the screening of total anti - Toxoplasma in human serum or plasma. | VIDAS® TOXO Compétition | BIOMERIEUX SA | |
18 | 03573026156855 | 30210-01 | TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family i TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma. | VIDAS® TOXO IgG II | BIOMERIEUX SA | |
19 | 03573026156824 | 30202-01 | TOXO IgM (TXM) assay is a qualitative IA intended for use on VIDAS family instr TOXO IgM (TXM) assay is a qualitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma. | VIDAS® TOXO IgM | BIOMERIEUX SA | |
20 | 00850487007616 | TOXO M | Q01-130 | Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
21 | 00850487007401 | TOXO G | Q01-120 | Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
22 | 00850487007036 | TOXO G | Q01-120 | Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
23 | 00850487007029 | TOXO M | Q01-130 | Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
24 | 00847865010702 | 25175 | 25175 | Toxoplasma IgG EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
25 | 00817273020143 | 720-310 | "720-310 Toxoplasma IgM Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
26 | 00817273020136 | 720-300 | "720-300 Toxoplasma IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
27 | 00817273020006 | 250-030 | Calibration Test Kit | Diamedix | DIAMEDIX CORPORATION | |
28 | 00816057020546 | NC-810096-AM | NC-810096-AM | Detection of Toxoplasma Antibody | ASI Toxoplasma IgM EIA Test | ARLINGTON SCIENTIFIC, INC. |
29 | 00816057020539 | NC-810096-AG | NC-810096-AG | Detection of Toxoplasma Antibody | ASI Toxoplasma IgG EIA Test | ARLINGTON SCIENTIFIC, INC. |
30 | 00811727015167 | T8002-96 | T8002-96 | Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quanti Pointe Scientific, Inc. Toxoplasma IgM Reagent is for the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay, to aid in the diagnosis of Toxoplasma infection. A positive result is presumptive for the detection of anti-Toxoplasma gondii antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. Patient testing with anti-Toxoplasma gondii IgM antibody assay, must be accompanied by an anti-Toxoplasma gondii IgG antibody assay. The assay’s performance characteristics have not been established for neonatal toxoplasmosis diagnosis. This assay has not been cleared / approved by the FDA for blood / plasma donor screening. 96 tests. | Pointe Scientific, Inc. Toxoplasma IgM | POINTE SCIENTIFIC, INC. |
31 | 00811727015150 | T8001-96 | T81001-96 | Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quan Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests | Pointe Scientific, Inc. Toxoplasma IgG | POINTE SCIENTIFIC, INC. |
32 | 00630414976747 | 10469600 | LTXPCM | Toxoplasma IGG - IMMULITE - CTL | IMMULITE® Systems TXP CONTROL Toxoplasma IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
33 | 00630414971483 | 10374023 | L2KTM2(D) | Toxoplasma IgM Ab - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems TXM Toxoplasma IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
34 | 00630414964805 | 10381268 | LKTXP1 | Toxoplasma IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
35 | 00630414962238 | 10381323 | L2KTXP2 | Toxoplasma IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems TXP Toxoplasma Quantitatve IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
36 | 00630414600154 | 10995702 | 10995702 | Toxoplasma M IgM (ToxM) QC Kit Atellica IM - CLT 2 x 2 x 1.5mL | Atellica IM Toxo M QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
37 | 00630414600147 | 10995701 | 10995701 | Toxoplasma M - IgM (ToxM) Atellica IM - RGT 50T | Atellica IM Toxo M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
38 | 00630414600130 | 10995700 | 10995700 | Toxoplasma G - IgG (ToxG) QC Kit Atellica IM - CLT 2 x 2 x 2.7mL | Atellica IM Toxo G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00630414600123 | 10995699 | 10995699 | Toxoplasma G - IgG (ToxG) Atellica IM - RGT 100T | Atellica IM Toxo G | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
40 | 00630414208763 | 10310326 | 120383 | TOXO IgM - CENTAUR - CONS - 2x2x1,5mL | ADVIA Centaur® Toxo M QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00630414208756 | 10310325 | 120382 | TOXO IgG - CENTAUR - CONS - 2x2x2,7mL | ADVIA Centaur® Toxo G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00630414208459 | 10310321 | 120154 | Toxoplasma IgG Ab - CENTAUR - RGT - 100 tests | ADVIA Centaur® Toxo G | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00630414208442 | 10310320 | 120153 | Toxoplasma IgM Ab - CENTAUR - RGT - 50 tests | ADVIA Centaur® Toxo M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 15099590624927 | A31588 | A31588 | The Access Toxo IgG assay is a paramagnetic particle, chemiluminescent immunoass The Access Toxo IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. | Access Toxo IgG | BECKMAN COULTER, INC. |
45 | 15099590624910 | A31589 | A31589 | The Access Toxo IgG Calibrators are intended to calibrate the Access Toxo IgG as The Access Toxo IgG Calibrators are intended to calibrate the Access Toxo IgG assay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. | Access Toxo IgG Calibrators | BECKMAN COULTER, INC. |
46 | 15099590624903 | A31590 | A31590 | The Access Toxo IgG QC is intended for monitoring system performance of the Acce The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay. | Access Toxo IgG QC | BECKMAN COULTER, INC. |
47 | 15099590624804 | 34470 | 34470 | The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoa The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. | Access Toxo IgM II | BECKMAN COULTER, INC. |
48 | 15099590624798 | 34475 | 34475 | The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in human serum and plasma using the Access Immunoassay Systems. | Access Toxo IgM II Calibrators | BECKMAN COULTER, INC. |
49 | 15099590624781 | 34479 | 34479 | The Access Toxo IgM II QC is intended for monitoring system performance of the A The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II assay. | Access Toxo IgM II QC | BECKMAN COULTER, INC. |