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 | 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 | |
2 | 00893029002571 | GIS-62-2ML | GIS-62-2ML | Urease Glycerol Solution | Urease | GI SUPPLY, INC. |
3 | 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. |
4 | 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. |
5 | 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. | |
6 | 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. | |
7 | 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. | |
8 | 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. | |
9 | 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. | |
10 | 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. | |
11 | 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. | |
12 | 00855574005414 | HP20 | H. Pylori, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
13 | 00850487007654 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. | |
14 | 00850487007647 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. | |
15 | 00850487007531 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
16 | 00850487007159 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
17 | 00840733102271 | 760130 | 760130 | Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluoresce Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | Curian HpSA | MERIDIAN BIOSCIENCE, INC. |
18 | 00840733101779 | 710030 | 710030 | The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative pro The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices. | ImmunoCard H. pylori | MERIDIAN BIOSCIENCE, INC. |
19 | 00840733101731 | 606096 | 606096 | Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative de Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative detection of IgG antibodies to Helicobacter pylori in human serum and plasma. Test results are intended to aid in the diagnosis of H. pylori infection. | PREMIER H. pylori | MERIDIAN BIOSCIENCE, INC. |
20 | 00840733101670 | 601396 | 601396 | The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitati The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. | PREMIER Platinum HpSA PLUS | MERIDIAN BIOSCIENCE, INC. |
21 | 00840733101427 | 610190 | 610190 | Curian is an Immunoassay Analyzer designed to automate incubation, results inter Curian is an Immunoassay Analyzer designed to automate incubation, results interpretation and results reporting of immunoassay diagnostic products. Curian is intended for use with Curian fluorescent immunoassay products. Curian-compatible Meridian Bioscience products are described in individual immunoassay package inserts. | Curian Analyzer | MERIDIAN BIOSCIENCE, INC. |
22 | 00840733101380 | 750220 | 750220 | The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the dete The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. | ImmunoCard STAT! HpSA | MERIDIAN BIOSCIENCE, INC. |
23 | 00817273020037 | 300-331A | 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit | Diamedix | DIAMEDIX CORPORATION | |
24 | 00816870022741 | 1475-300 | 1475-300A | Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells | MONOBIND, INC. | |
25 | 00816870022734 | 1575-300 | 1575-300A | Monobind AccuLite Anti-H. Pylori IgG CLIA Kit - 96 Wells | MONOBIND, INC. | |
26 | 00816870022727 | 1675-300 | 1675-300A | Monobind AccuLite Anti-H. Pylori IgA CLIA Kit - 96 Wells | MONOBIND, INC. | |
27 | 00816870021102 | 1425-300 | 1425-300A | Monobind AccuBind Anti-H. Pylori IgM ELISA Kit - 96 Wells | MONOBIND, INC. | |
28 | 00816870021096 | 1525-300 | 1525-300A | Monobind AccuBind Anti-H. Pylori IgG ELISA Kit - 96 Wells | MONOBIND, INC. | |
29 | 00816870021089 | 1625-300 | 1625-300A | Monobind AccuBind Anti-H. Pylori IgA ELISA Kit - 96 Wells | MONOBIND, INC. | |
30 | 00742860100161 | 175 | 175 | OSOM H Pylori 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
31 | 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 |
32 | 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 | |
33 | 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. |
34 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | IMMULITE® Systems HPG CONTROL H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
35 | 00630414964164 | 10381272 | LKHPG1 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
36 | 00630414961644 | 10381335 | L2KHPG6 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
37 | 00630414961637 | 10381336 | L2KHPG2 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
38 | 00630414960944 | 10385353 | L1KIDW1 | Infectious Disease Diluent - IMMULITE - CAL | IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
39 | 00613647000519 | 4581465021 | 23900535 | SURE-VUE H. PYLORI 30/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
40 | 00612479202719 | 5007 | TEST KIT, H PYLORI (10/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
41 | 00612479202702 | 5008 | TEST KIT, H PYLORI (25/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
42 | 00350770927459 | 92745 | 60480 | AVANOS* CLOTEST* Rapid Urease Test | AVANOS | AVANOS MEDICAL, INC. |
43 | 00350770926636 | 92663 | 60407 | HALYARD* CLOTEST* Jack Bean Urease Control Tablets | AVANOS | AVANOS MEDICAL, INC. |
44 | 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. | |
45 | 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 | |
46 | 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 | |
47 | 50192253013717 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
48 | 50192253012239 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
49 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | QuickVue | QUIDEL CORPORATION |
50 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | QuickVue | QUIDEL CORPORATION |