| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 05391516749169 | 40-3022L | 40-3022L | HEp-2 WB IgG Positive Control, 250 µL | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Trinity Biotech |
| 2 | 05391516749152 | 40-2030 | 40-2030 | Sample Diluent/Wash Powder , 5g | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 3 | 05391516749145 | 40-2024G | 40-2024G | Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5ml | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 4 | 05391516749138 | 40-5023 | 40-5023 | T. pallidum WB IgG Positive Control, 250µl | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 5 | 05391516749121 | 40-5021 | 40-5021 | T. pallidum WB Negative Control, 250µl | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 6 | 05391516749114 | 40-5018 | 40-5018 | T. pallidum Marblot Strip, 20 each pack | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 7 | 05391516749107 | 30-1527 | 30-1527 | L. pneumophila, 1-14, DFA Test Conjugate, (Primate), 1.5 ml | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Trinity Biotech |
| 8 | 05391516749091 | 30-7104 | 30-7104 | L. pneumophila Slides, Serogroups 1-6 Column, pack of 10 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Trinity Biotech |
| 9 | 05391516749084 | 30-1526 | 30-1526 | Legionella species, b-j, Test Conjugate, (Primate), 1.5 mL | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Trinity Biotech |
| 10 | 05391516749077 | 30-7100 | 30-7100 | DFA 2 well Slide, 25 each pack | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Trinity Biotech |
| 11 | 05391516749015 | 30-7108 | 30-7108 | Legionella species, b-j, control slides, pack of 10 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Trinity Biotech |
| 12 | 05391516748926 | 20-04002 | 20-04002 | Leishmania species Positive Control, 250 µL | LOO | Reagent, Leishmanii Serological | 1 | Trinity Biotech |
| 13 | 05391516748919 | 20-04006 | 20-04006 | Leishmania species, 6 Well Slide, 8 each pack | LOO | Reagent, Leishmanii Serological | 1 | Trinity Biotech |
| 14 | 05391516748902 | 32-5001 | 32-5001 | Lyme Negative Control, 250 uL | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
| 15 | 05391516748896 | 10-1502N | 10-1502N | Primate Adsorbed FITC Bulk Conjugate with Evan’s Blue, 4.0 mL | MVU | Reagents,Specific,Analyte | 1 | Trinity Biotech |
| 16 | 05391516748889 | 20-03012 | 20-03012 | Trypanosoma cruzi 12 well slide, 8 each pack | MIV | Immunofluorescent Assay, T. Cruzi | 1 | Trinity Biotech |
| 17 | 05391516748872 | 20-90215 | 20-90215 | FITC Parasite IgG Conjugate (Rodent), 4.0 mL | MIV | Immunofluorescent Assay, T. Cruzi | 1 | Trinity Biotech |
| 18 | 05391516748865 | 20-03006 | 20-03006 | Trypanosoma cruzi 6 Well Slide, 8 each pack | MIV | Immunofluorescent Assay, T. Cruzi | 1 | Trinity Biotech |
| 19 | 05391516748858 | B1029-70C | B1029-70C | Clostridium difficile Antitoxin, 3 mL | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 20 | 05391516748841 | B1029-70B | B1029-70B | Toxi-Titer Diluent, 50 mL | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 21 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | LYR | Helicobacter Pylori | 1 | Trinity Biotech |
| 22 | 05391516748810 | 1204420 | 1204420 | Uni-Gold™ S. pneumoniae, 20 Tests | GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | Trinity Biotech |
| 23 | 05391516748803 | 1206641 | 1206641 | Uni-Gold™ C. difficile GDH Controls, 1 Positive and 1 Negative | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 24 | 05391516748797 | 1206640 | 1206640 | Uni-Gold™ C. difficile GDH, 20 Tests | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 25 | 05391516748780 | 1206631 | 1206631 | Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative | LLH | Reagents, Clostridium Difficile Toxin | 1 | Trinity Biotech |
| 26 | 05391516748773 | 1206630 | 1206630 | Uni-Gold™ C. difficile Toxin A/B, 20 Tests | LLH | Reagents, Clostridium Difficile Toxin | 1 | Trinity Biotech |
| 27 | 05391516747943 | 90-1610 | 90-1610 | FITC Mounting Medium (pH 7.5), 3.0 mL | LEB,MVJ,NUK,MIV,NUL,LOO,LSR | Mounting Media,Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm Mounting Media,Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm),For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System,Immunofluorescent Assay, T. Cruzi,For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System,Reagent, Leishmanii Serological,Reagent, Borrelia Serological Reagent | 1 | Trinity Biotech |
| 28 | 05391516748766 | 1206711 | 1206711 | Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
| 29 | 05391516748759 | 1206710 | 1206710 | Uni-Gold™ Syphilis Treponemal, 20 Tests | LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | Trinity Biotech |
| 30 | 05391516748742 | 44-2020M | 44-2020M | EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM An EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
| 31 | 05391516748735 | 44-2020GV | 44-2020GV | EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of I EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
| 32 | 05391516747974 | 40-5065M/B-A | 40-5065M/B-A | B. burgdorferi (IgM) Marblot Strip Test System, 400 Tests | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
| 33 | 05391516748728 | 41-1020G | 41-1020G | Liver (IgG) Marblot Strip Test System, Western Blot System for the Detection of Liver (IgG) Marblot Strip Test System, Western Blot System for the Detection of IgG Antibody to Liver Antigens, 20 Tests | NBS | Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1) | 2 | Trinity Biotech |
| 34 | 05391516748711 | 40-5020M | 40-5020M | T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detectio T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detection of IgM antibody to T. pallidum, 20 Tests | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 35 | 05391516748704 | 40-5020G | 40-5020G | T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detectio T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibody to T. pallidum, 20 Tests | JWL | Antigen, Treponema Pallidum For Fta-Abs Test | 2 | Trinity Biotech |
| 36 | 05391516748698 | 20-04648 | 20-04648 | Leismaniasis IFA Test System, 48 Tests | LOO | Reagent, Leishmanii Serological | 1 | Trinity Biotech |
| 37 | 05391516748681 | 20-03648 | 20-03648 | Trypanosomiasis IFA Test System, 48 Tests | MIV | Immunofluorescent Assay, T. Cruzi | 1 | Trinity Biotech |
| 38 | 05391516748049 | 10-5808 | 10-5808 | Monkey Kidney 8 Well Slides, 12 each pack | NUL | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System | Trinity Biotech | |
| 39 | 05391516748032 | 10-5804 | 10-5804 | Monkey Skeletal 4 Well Slides, 12 each pack | NUL | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System | Trinity Biotech | |
| 40 | 05391516748025 | 10-5848 | 10-5848 | Anti Skeletal Antibody IFA Test System, 48 Tests | NUL | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System | Trinity Biotech | |
| 41 | 05391516748018 | 10-5602 | 10-5602 | GBM Positive Control, 0.5 mL | MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 2 | Trinity Biotech |
| 42 | 05391516748001 | 10-5648 | 10-5648 | Glomerular Basement Membrane IFA Test System, 48 Tests | MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 2 | Trinity Biotech |
| 43 | 05391516747998 | B1029-70D | B1029-70D | Toxi-Titer Plate, 48 Wells | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 44 | 05391516747981 | 30-1523 | 30-1523 | Legionella Negative DFA Control Conjugate, 1.5 mL | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Trinity Biotech |
| 45 | 05391516747967 | 40-5065G/B-A | 40-5065G/B-A | B. burgdorferi (IgG) Marblot Strip Test System (400 Tests) | LSR | Reagent, Borrelia Serological Reagent | 2 | Trinity Biotech |
| 46 | 05391516747950 | B1029-70 | B1029-70 | Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, St Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 47 | 05391516747936 | B1029-70A | B1029-70A | Clostridium difficile Toxin Control, 1.0 mL | MCB | Antigen, C. Difficile | 1 | Trinity Biotech |
| 48 | 05391516747929 | 90-1700 | 90-1700 | Coverslips, 70x22 mm, 12 each | KES,LHL,LSR | Coverslips, Microscope Slide,Reagents, Antibody, Legionella, Direct & Indirect F Coverslips, Microscope Slide,Reagents, Antibody, Legionella, Direct & Indirect Fluorescent,Reagent, Borrelia Serological Reagent | 1 | Trinity Biotech |
| 49 | 05391516747912 | 90-1611 | 90-1611 | FITC Mounting Medium (pH 7.5), 3.0 mL | LHL,GMS | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent,Anti-Human Globuli Reagents, Antibody, Legionella, Direct & Indirect Fluorescent,Anti-Human Globulin, Fta-Abs Test | 2 | Trinity Biotech |
| 50 | 05391516747899 | 40-6196P | 40-6196P | B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordet B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests | GOX | Antigen, B. Pertussis | 1 | Trinity Biotech |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10815845020079 | 01P53-25 | Signify® | ALERE SAN DIEGO, INC. | ||
| 2 | 10815845020048 | 92405 | Clearview® | ALERE SAN DIEGO, INC. | ||
| 3 | 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. | |
| 4 | 10796918001839 | 05-9475 | INSTANT-VIEW H. pylori Rapid Test | INSTANT-VIEW H. pylori Rapid Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 5 | 10796918001822 | 05-9473 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 6 | 10796918001815 | 05-9472 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 7 | 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 | |
| 8 | 10743816001591 | BSP-406WB-25-02 | Status™ H. pylori card; 25 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
| 9 | 10743816001584 | BSP-406WB-10-02 | Status™ H. pylori card; 10 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
| 10 | 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 |
| 11 | 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 |
| 12 | 10743816001140 | BSP-406WB-10-01 | BSP-406WB-10-01 | BioSign® H. pylori card; 10 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
| 13 | 10743816001133 | BSP-406WB-35-01 | BSP-406WB-35-01 | BioSign® H. pylori card; 35 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
| 14 | 10722355002023 | IHP-30 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
| 15 | 10722355002016 | IHP-10 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
| 16 | 10304040155742 | 5702778 | 5702778 | Henry Schein One Step + H. Pylori | Henry Schein | HENRY SCHEIN, INC. |
| 17 | 10304040024154 | 9004071 | 9004071 | One Step + H Pylori Test | Henry Schein | HENRY SCHEIN, INC. |
| 18 | M220P0800953 | P080095 | P080095 | PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
| 19 | 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 |
| 20 | 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 |
| 21 | 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. | |
| 22 | 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. | |
| 23 | 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. | |
| 24 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 25 | 05391516748827 | 1206650 | 1206650 | Uni-Gold™ H. pylori Antigen, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 26 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 27 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 28 | 05391516747714 | 40-1006 | 40-1006 | EIA Color Developer, 13.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
| 29 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
| 30 | 05391516743686 | 2326430 | 2326430 | Captia™ H. pylori IgA | Trinity Biotech | CLARK LABORATORIES, INC. |
| 31 | 05391516743679 | 2346400 | 2346400 | Captia™ H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
| 32 | 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 | |
| 33 | 00893029002571 | GIS-62-2ML | GIS-62-2ML | Urease Glycerol Solution | Urease | GI SUPPLY, INC. |
| 34 | 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. |
| 35 | 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. |
| 36 | 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. | |
| 37 | 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. | |
| 38 | 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. | |
| 39 | 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. | |
| 40 | 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. | |
| 41 | 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. | |
| 42 | 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. | |
| 43 | 00855574005414 | HP20 | H. Pylori, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
| 44 | 00850487007654 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. | |
| 45 | 00850487007647 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. | |
| 46 | 00850487007531 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
| 47 | 00850487007159 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
| 48 | 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. |
| 49 | 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. |
| 50 | 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. |