No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850487007289 | Anti-dsDNA | Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | ReQuest | |
2 | 00850487007258 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | ReQuest |
3 | 00850487007241 | Anti-TG | 1 | Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) | DDC | Thyroglobulin, Antigen, Antiserum, Control | 2 | ReQuest |
4 | 00850487007234 | Anti-TPO | Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immu Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) | JZO | System, Test, Thyroid Autoantibody | 2 | ReQuest | |
5 | 00850487007227 | Cardiolipin G | Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) | MID | System, Test, Anticardiolipin Immunological | 2 | ReQuest | |
6 | 00850487007210 | CMV G | Q01-140 | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoa Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | ReQuest |
7 | 00850487007203 | CMV M | Q01-150 | Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | ReQuest |
8 | 00850487007197 | EB EA-D G | Q01-490 | Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LSE | Epstein-Barr Virus, Other | 1 | ReQuest |
9 | 00850487007173 | EB VCA M | Q01-480 | Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme im Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | ReQuest |
10 | 00850487007166 | EB NA G | Q01-460 | Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, k Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LSE | Epstein-Barr Virus, Other | 1 | ReQuest |
11 | 00850487007159 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LYR | Helicobacter Pylori | 1 | ReQuest |
12 | 00850487007128 | HSV Type 2 G | Q01-420 | Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme i Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | ReQuest |
13 | 00850487007104 | MEAS M | Q01-190M | Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | ReQuest |
14 | 00850487007098 | MUMPS G | Q01-200 | Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | ReQuest |
15 | 00850487007081 | Mumps M | Q01-200M | Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | ReQuest |
16 | 00850487007074 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | ReQuest |
17 | 00850487007067 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | ReQuest |
18 | 00850487007050 | Sm/RNP | Q01-240 | Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) | LKP | Anti-Sm Antibody, Antigen And Control | 2 | ReQuest |
19 | 00850487007043 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | ReQuest |
20 | 00850487007036 | TOXO G | Q01-120 | Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | ReQuest |
21 | 00850487007029 | TOXO M | Q01-130 | Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | ReQuest |
22 | 00850487007005 | Anti-SSA | Q01-250 | SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | ReQuest |
23 | 00850487007654 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | LYR | Helicobacter Pylori | 1 | SeraQuest | |
24 | 00850487007647 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | LYR | Helicobacter Pylori | 1 | ReQuest | |
25 | 00850487007630 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | SeraQuest |
26 | 00850487007623 | ENA Screen | 01-330 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | ReQuest |
27 | 00850487007616 | TOXO M | Q01-130 | Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | SeraQuest |
28 | 00850487007609 | Syphilis G | Q01-580 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | SeraQuest |
29 | 00850487007593 | Sm/RNP | Q01-240 | Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) | LKP | Anti-Sm Antibody, Antigen And Control | 2 | SeraQuest |
30 | 00850487007586 | Mumps M | Q01-200M | Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | SeraQuest |
31 | 00850487007579 | MUMPS G | Q01-200 | Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | SeraQuest |
32 | 00850487007562 | MEAS M | Q01-190M | Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | SeraQuest |
33 | 00850487007555 | HSV Type 2 G | Q01-420 | Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme i Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | SeraQuest |
34 | 00850487007548 | HSV Type 1 G | 01-410 | Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme i Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | SeraQuest |
35 | 00850487007524 | EBV-EA G | Q01-490 | Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LSE | Epstein-Barr Virus, Other | 1 | SeraQuest |
36 | 00850487007517 | Cardiolipin G | Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) | MID | System, Test, Anticardiolipin Immunological | 2 | SeraQuest | |
37 | 00850487007500 | Anti-TPO | Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immu Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) | JZO | System, Test, Thyroid Autoantibody | 2 | SeraQuest | |
38 | 00850487007494 | Anti-TG | Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) | DDC | Thyroglobulin, Antigen, Antiserum, Control | 2 | SeraQuest | |
39 | 00850487007487 | Anti-SSB | Q01-260 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | SeraQuest |
40 | 00850487007470 | Anti-SSA | Q01-250 | SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | SeraQuest |
41 | 00850487007463 | Anti-Sm | Q01-230 | Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA) | SeraQuest | |||
42 | 00850487007456 | Anti SCL 70 | 01-270H | Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | SeraQuest |
43 | 00850487007449 | Anti-dsDNA | Q01-210 | Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) | LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | SeraQuest |
44 | 00850487007432 | Anti Jo1 | 01-280H | Jo-1 antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | |||
45 | 00850487007425 | ANA Screen | Q01-310H | Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) | LKJ | Antinuclear Antibody, Antigen, Control | 2 | SeraQuest |
46 | 00850487007418 | EB VCA M | Q01-480 | Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme im Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | SeraQuest |
47 | 00850487007401 | TOXO G | Q01-120 | Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | SeraQuest |
48 | 00850487007395 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | SeraQuest |
49 | 00850487007388 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | SeraQuest |
50 | 00850487007371 | EB VCA G | Q01-470 | Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme im Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | LSE | Epstein-Barr Virus, Other | 1 | SeraQuest |
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 |