No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B350GSD341600R0 | GSD34-1600-R | GSD34-1600-R | Rapid Plasma Reagin (RPR) Reagent Pack | Gold Standard Diagnostics RPR Reagent Pack | |||
2 | B350GSD0110260 | GSD01-1026 | GSD01-1026 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit |
3 | B350GSD011002HCP0 | GSD01-1002-HCP | GSD01-1002-HCP | H. pylori Component Pack | PPM | General Purpose Reagent | 1 | H. pylori Component Pack |
4 | B3507206300 | 720-630 | 720-630 | ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determinatio ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear Antigen-1 (EBNA-1 IgM) in human serum by indirect enzyme immunoassay. | LSE | Epstein-Barr Virus, Other | 1 | Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit |
5 | B3507205200 | 720-520 | 720-520 | ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to me ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection. | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit |
6 | B3507203200 | 720-320 | 720-320 | ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytome ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals. | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit |
7 | B350GSD1600WCASE0 | GSD-1600-W-CASE | GSD-1600-W-CASE | Microtiterplates 48-well microtiter plates - bulk | GMQ | Antigens, Nontreponemal, All | 2 | Microtiterplates |
8 | B350GSD0610190 | GSD06-1019 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit - Bulk | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit | |
9 | B350GSD0130020 | GSD01-3002 | GSD01-3002 | Trichinella spiralis IgG ELISA Test Kit | MDT | Elisa, Trichinella Spiralis | 1 | Trichinella spiralis IgG ELISA Test Kit |
10 | B350GSD0130000 | GSD01-3000 | GSD01-3000 | Toxocara canis IgG ELISA Test Kit | MDJ | Reagents, Cysticercosis | 1 | GSD Toxocara canis IgG ELISA |
11 | B350GSD0110280 | GSD01-1028 | GSD01-1028 | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit | |
12 | B350GSD0110270 | GSD01-1027 | GSD01-1027 | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit |
13 | B350GSD0110250 | GSD01-1025 | GSD01-1025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit |
14 | B350GSD0110240 | GSD10-1024 | GSD10-1024 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit |
15 | 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. | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit |
16 | B350005000 | 00500 | 00500 | Bolt EIA | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Bolt |
17 | B350GSD0130070 | GSD01-3007 | GSD01-3007 | Brucella IgG ELISA Test Kit | GSM | Antisera, Fluorescent, Brucella Spp. | 2 | GSD Brucella IgG ELISA |
18 | B350GSD0130010 | GSD01-3001 | GSD01-3001 | Toxocara canis IgG ELISA Test Kit | MDJ | Reagents, Cysticercosis | 1 | Toxocara canis IgG ELISA Test Kit |
19 | B35000300CL0 | 00300-CL | 00300CL | ThunderBolt EIA-CLIA | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ThunderBolt EIA (CLIA) |
20 | B350GSD1010220 | GSD10-1022 | GSD10-1022 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - 10 Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit |
21 | B350GSD0610180 | GSD06-1018 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - Bulk | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | |
22 | B350GSD051700AW0 | GSD05-1700-AW | GSD05-1700-AW | HHV-6 IgG Plates - Bulk | MVU | Reagents, Specific, Analyte | 1 | HHV-6 IgG Plates - Bulk |
23 | B350GSD0113000 | GSD01-1300 | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | |
24 | B350GSD011029CP0 | GSD01-1029-CP | GSD01-1029-CP | SARS-CoV-2 Component Pack | PPM | General Purpose Reagent | 1 | SARS-CoV-2 Component Pack |
25 | B350GSD0110220 | GSD01-1022 | GSD01-1022 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit |
26 | B350GSD0110180 | GSD01-1018 | GSD01-1018 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit |
27 | B3507203500 | 720-350 | 720-350 | ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit |
28 | B350GSD0410220 | GSD04-1022 | GSD04-1022 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk |
29 | B3507205400 | 720-540 | 720-540 | ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-q ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection. | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit |
30 | B3507202800 | 720-280 | 720-280 | ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease. | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit |
31 | B350GSD051700CP0 | GSD05-1700-CP | GSD05-1700-CP | IgG Component Pack - Bulk | PPM | General Purpose Reagent | 1 | IgG Component Pack - Bulk |
32 | B350GSD0130100 | GSD01-3010 | GSD01-3010 | Gold Standard Diagnostics Influenza B IgG ELISA Test Kit | GNW | Antisera, Cf, Influenza Virus A, B, C | 1 | Influenza B IgG ELISA Test Kit |
33 | B350GSD0110300 | GSD01-1030 | GSD01-1030 | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit | |
34 | B350GSD011029SP0 | GSD01-1029-SP | GSD01-1029-SP | SARS-CoV-2 IgA Sera PackAnalyte Specific Reagent | MVU | Reagents, Specific, Analyte | 1 | SARS-CoV-2 IgA Sera Pack |
35 | B35000500CL0 | 00500-CL | 00500CL | Bolt EIA-CLIA | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Bolt (CLIA) |
36 | B350003000 | 00300 | 00300 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ThunderBolt EIA | |
37 | B350GSD0116000 | GSD01-1600 | Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit | GMQ | Antigens, Nontreponemal, All | 2 | Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System | |
38 | B350GSD011002CP0 | GSD01-1002-CP | GSD01-1002-CP | H. pylori IgM Sera Pack | MVU | Reagents, Specific, Analyte | 1 | H. pylori IgM Sera Pack |
39 | B350GSD0110000 | GSD01-1000 | Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit | LYR | Helicobacter Pylori | 1 | Gold Standard Diagnostics H. pylori ELISA IgG Test Kit | |
40 | B3507203400 | 720-340 | 720-340 | ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit |
41 | B350004000 | 00400 | AIX1000 Rapid Plasma Reagin (RPR) Analyzer | GMQ | Antigens, Nontreponemal, All | 2 | AIX1000 Analyzer | |
42 | B350GSD1010230 | GSD10-1023 | GSD10-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit |
43 | B350GSD0410230 | GSD04-1023 | GSD04-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk |
44 | B350GSD0110290 | GSD01-1029 | GSD01-1029 | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit | |
45 | B350GSD0110230 | GSD01-1023 | GSD01-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit |
46 | B350GSD0110190 | GSD01-1019 | GSD01-1019 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit |
47 | B3507203800 | 720-380 | 720-380 | ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitat ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection. | LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 2 | Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 20885380183642 | CH25 | CH25 | CH25 Cardinal Health H. pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
2 | 20885380163583 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
3 | 20885380163576 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
4 | 20885380020282 | B1077-25 | B1077-25 | H.pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
5 | 15099590625924 | 395160 | 395160 | ICON HP (30 Tests) | Icon | BECKMAN COULTER, INC. |
6 | 10815845020079 | 01P53-25 | Signify® | ALERE SAN DIEGO, INC. | ||
7 | 10815845020048 | 92405 | Clearview® | ALERE SAN DIEGO, INC. | ||
8 | 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. | |
9 | 10796918001839 | 05-9475 | INSTANT-VIEW H. pylori Rapid Test | INSTANT-VIEW H. pylori Rapid Test | ALFA SCIENTIFIC DESIGNS, INC. | |
10 | 10796918001822 | 05-9473 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
11 | 10796918001815 | 05-9472 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
12 | 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 | |
13 | 10743816001591 | BSP-406WB-25-02 | Status™ H. pylori card; 25 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
14 | 10743816001584 | BSP-406WB-10-02 | Status™ H. pylori card; 10 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
15 | 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 |
16 | 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 |
17 | 10743816001140 | BSP-406WB-10-01 | BSP-406WB-10-01 | BioSign® H. pylori card; 10 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
18 | 10743816001133 | BSP-406WB-35-01 | BSP-406WB-35-01 | BioSign® H. pylori card; 35 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
19 | 10722355002023 | IHP-30 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
20 | 10722355002016 | IHP-10 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
21 | 10304040155742 | 5702778 | 5702778 | Henry Schein One Step + H. Pylori | Henry Schein | HENRY SCHEIN, INC. |
22 | 10304040024154 | 9004071 | 9004071 | One Step + H Pylori Test | Henry Schein | HENRY SCHEIN, INC. |
23 | M220P0800953 | P080095 | P080095 | PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
24 | 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 |
25 | 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 |
26 | 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. | |
27 | 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. | |
28 | 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. | |
29 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
30 | 05391516748827 | 1206650 | 1206650 | Uni-Gold™ H. pylori Antigen, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
31 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
32 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
33 | 05391516747714 | 40-1006 | 40-1006 | EIA Color Developer, 13.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
34 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
35 | 05391516743686 | 2326430 | 2326430 | Captia™ H. pylori IgA | Trinity Biotech | CLARK LABORATORIES, INC. |
36 | 05391516743679 | 2346400 | 2346400 | Captia™ H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
37 | 03573026509231 | 30192-01 | VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA). | VIDAS® H. pylori IgG | BIOMERIEUX SA | |
38 | 00893029002571 | GIS-62-2ML | GIS-62-2ML | Urease Glycerol Solution | Urease | GI SUPPLY, INC. |
39 | 00893029002519 | GIS-22 | GIS-22 | HpFast detects the urease enzyme for the presumptive identification of Helicobac HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. | HpFast | GI SUPPLY, INC. |
40 | 00893029002502 | GIS-64 | GIS-64 | HpOne detects the urease enzyme for the presumptive identification of Helicobact HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. | HpOne | GI SUPPLY, INC. |
41 | 00857031002639 | T5051B | The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI CHEK | TECHLAB, INC. | |
42 | 00857031002622 | 20343 | The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoa The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | QuickVue TLI H. pylori Stool Antigen Test | TECHLAB, INC. | |
43 | 00857031002561 | 20343 | The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the q The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | QuickVue TLI H. pylori Test | TECHLAB, INC. | |
44 | 00857031002523 | 30996 | The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI CHEK | TECHLAB, INC. | |
45 | 00857031002516 | 30925 | The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI QUIK CHEK | TECHLAB, INC. | |
46 | 00857031002509 | T5051 | The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI CHEK | TECHLAB, INC. | |
47 | 00857031002493 | T5050 | The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI QUIK CHEK | TECHLAB, INC. | |
48 | 00855574005414 | HP20 | H. Pylori, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
49 | 00850487007654 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. | |
50 | 00850487007647 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |