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 | 00817273020099 | 72-260 | 720-260 anti-SSB Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
40 | 00817273020082 | 720-250 | 720-250 anti-SSA Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
41 | 00817273020075 | 720-240 | 720-240 anti-SM Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
42 | 00817273020068 | 720-230 | 720-230 ENA-6 Screen Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
43 | 00817273020051 | 720-130 | 720-130 H.pylori IgG Test Kit | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Diamedix | |
44 | 00817273020044 | 300-371A | "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit" | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 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 | 00742860100161 | 175 | 175 | OSOM H Pylori 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
2 | 00722066000304 | HPY-13C15 | HPY-13C15 | Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma. | Rapid Response | BTNX INC |
3 | 00695684330200 | 33020 | A rapid cassette test for the qualitative detection of Helicobabacter pylori in A rapid cassette test for the qualitative detection of Helicobabacter pylori in serum, plasma, or whole blood. | AIMSTEP H. PYLORI | GERMAINE LABORATORIES, INC | |
4 | 00657498000014 | 6300-020 | 6300-020 | For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. | RELY® H.Pylori | STANBIO LABORATORY, L.P. |
5 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | IMMULITE® Systems HPG CONTROL H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
6 | 00630414964164 | 10381272 | LKHPG1 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
7 | 00630414961644 | 10381335 | L2KHPG6 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
8 | 00630414961637 | 10381336 | L2KHPG2 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
9 | 00630414960944 | 10385353 | L1KIDW1 | Infectious Disease Diluent - IMMULITE - CAL | IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
10 | 00613647000519 | 4581465021 | 23900535 | SURE-VUE H. PYLORI 30/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
11 | 00612479202719 | 5007 | TEST KIT, H PYLORI (10/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
12 | 00612479202702 | 5008 | TEST KIT, H PYLORI (25/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
13 | 00350770927459 | 92745 | 60480 | AVANOS* CLOTEST* Rapid Urease Test | AVANOS | AVANOS MEDICAL, INC. |
14 | 00350770926636 | 92663 | 60407 | HALYARD* CLOTEST* Jack Bean Urease Control Tablets | AVANOS | AVANOS MEDICAL, INC. |
15 | 00083059070040 | 7004 | The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antib The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori. | GAP®-IgG (Gastritis and Peptic Ulcer Test) | BIOMERICA, INC. | |
16 | B350GSD0110010 | GSD01-1001 | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
17 | B350GSD0110000 | GSD01-1000 | Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit | Gold Standard Diagnostics H. pylori ELISA IgG Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
18 | 50192253013717 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
19 | 50192253012239 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
20 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | QuickVue | QUIDEL CORPORATION |
21 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | QuickVue | QUIDEL CORPORATION |
22 | 20885380183642 | CH25 | CH25 | CH25 Cardinal Health H. pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
23 | 20885380163583 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
24 | 20885380163576 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
25 | 20885380020282 | B1077-25 | B1077-25 | H.pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
26 | 15099590625924 | 395160 | 395160 | ICON HP (30 Tests) | Icon | BECKMAN COULTER, INC. |
27 | 10815845020079 | 01P53-25 | Signify® | ALERE SAN DIEGO, INC. | ||
28 | 10815845020048 | 92405 | Clearview® | ALERE SAN DIEGO, INC. | ||
29 | 10796918001846 | 05-9494 | INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test | INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
30 | 10796918001839 | 05-9475 | INSTANT-VIEW H. pylori Rapid Test | INSTANT-VIEW H. pylori Rapid Test | ALFA SCIENTIFIC DESIGNS, INC. | |
31 | 10796918001822 | 05-9473 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
32 | 10796918001815 | 05-9472 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
33 | 10763924392206 | ID392 | ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* | ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* | JANT PHARMACAL CORPORATION | |
34 | 10743816001591 | BSP-406WB-25-02 | Status™ H. pylori card; 25 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
35 | 10743816001584 | BSP-406WB-10-02 | Status™ H. pylori card; 10 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
36 | 10743816001164 | BSP-406WB-30-07 | BSP-406WB-30-07 | Status™ H. pylori card; 30 Test kit- CE (Procedure Card) | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
37 | 10743816001157 | BSP-406WB-30-05 | BSP-406WB-30-05 | BioSign® H. pylori card; 30 Test kit (Procedure Card) | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
38 | 10743816001140 | BSP-406WB-10-01 | BSP-406WB-10-01 | BioSign® H. pylori card; 10 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
39 | 10743816001133 | BSP-406WB-35-01 | BSP-406WB-35-01 | BioSign® H. pylori card; 35 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
40 | 10722355002023 | IHP-30 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
41 | 10722355002016 | IHP-10 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
42 | 10304040155742 | 5702778 | 5702778 | Henry Schein One Step + H. Pylori | Henry Schein | HENRY SCHEIN, INC. |
43 | 10304040024154 | 9004071 | 9004071 | One Step + H Pylori Test | Henry Schein | HENRY SCHEIN, INC. |
44 | M220P0800953 | P080095 | P080095 | PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
45 | M1745140S1 | 05140S | 05140S | The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION |
46 | M1745140K1 | 05140K | 05140K | The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION |
47 | 08426950593805 | 708720 | 1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder2. 1x 1. 1. 1x H. pylori IgA ELISA microwell plate, (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgA ELISA Low Positive4. 1x 1.2mL prediluted H. pylori IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® H.pylori IgA ELISA | INOVA DIAGNOSTICS, INC. | |
48 | 08426950593256 | 708715 | 1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® H.pylori IgG ELISA | INOVA DIAGNOSTICS, INC. | |
49 | 08305900070040 | 7004 | The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antib The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori. | GAP®-IgG (Gastritis and Peptic Ulcer Test) | BIOMERICA, INC. | |
50 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |