No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00630414998947 | 10285226 | LSHCM | SHBG - IMMULITE - CTL - 1x1x2mL | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | IMMULITE® SBG Control SHBG |
2 | 00630414995939 | 10386016 | M15L2 | Trichoderma viride -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Trichoderma viride |
3 | 00630414995922 | 10386017 | M16L2 | Curvularia lunata -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Curvularia lunata |
4 | 00630414995823 | 10386113 | T96L2 | Poplar-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Poplar |
5 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | LYR | Helicobacter pylori | 1 | IMMULITE® Systems HPG CONTROL H.pylori IgG |
6 | 00630414988122 | 10368597 | A89L2 | Native Bet v 1-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nBet v 1 |
7 | 00630414986081 | 10642238 | LSKTI1(D) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | IMMULITE®/IMMULITE® 1000 Systems RTI Turbo Troponin I | |
8 | 00630414984599 | 10485107 | L2SNCCM | Specific IgE Neg - IMMULITE - CTL - 1x4mL | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control |
9 | 00630414984575 | 10485105 | DC2LCM | Specific IgE D2 - IMMULITE - CTL - 1x4mL | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 |
10 | 00630414984452 | 10381168 | LKUE31 | Estriol unconjugated - IMMULITE - RGT - 100 Tests | CGI | RADIOIMMUNOASSAY, ESTRIOL | 1 | IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol |
11 | 00630414979182 | 10386153 | W37L2 | Saltbush-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Saltbush |
12 | 00630414979113 | 10386135 | W14L2 | Rough Pigweed -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Rough Pigweed |
13 | 00630414979021 | 10386092 | T41L2 | White Hickory-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Hickory |
14 | 00630414978994 | 10386088 | T401L2 | Brazilian Peppertree-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Brazilian Peppertree |
15 | 00630414978987 | 10386085 | T37L2 | White Bald Cypress-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Bald Cypress |
16 | 00630414978895 | 10386050 | O201L2 | Tobacco-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tabacco |
17 | 00630414978611 | 10385835 | F50L2 | Chub Mackerel-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Chub Makerel |
18 | 00630414978543 | 10385755 | F261L2 | Asparagus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Asparagus |
19 | 00630414977478 | 10487239 | L2KPF2(D) | fPS Free PSA Kit 200 Test | MTG | Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cance Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | IMMULITE® 2000 Systems fPS Free PSA |
20 | 00630414976686 | 10469593 | LSYCM | Syphillis - IMMULITE - CTL - 2x6mL | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | IMMULITE® Systems SYP CONTROL Syphilis Screen |
21 | 00630414973548 | 10386060 | T15L2 | White Ash -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ White Ash |
22 | 00630414973326 | 10385714 | F20L2 | Almond -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Almond |
23 | 00630414973227 | 10385774 | F284L2 | Turkey Meat-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Turkey Meat |
24 | 00630414972947 | 10385998 | K84L2 | Sunflower-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Sunflower |
25 | 00630414972527 | 10385789 | F306L2 | Lime-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Lime |
26 | 00630414971377 | 10373705 | LTBCVM | TBG CVM - IMMULITE - CONS | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems TBG Calibration Verification Material TBG |
27 | 00630414971247 | 10373691 | LFT4CVM | Free T4 CVM - IMMULITE - | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems F4 Calibration Verification Material Free T4 |
28 | 00630414971155 | 10373682 | LBRCVM | BR-MA - IMMULITE - CONS | JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 1 | IMMULITE® Systems BR-MA Calibration Verification Material |
29 | 00630414970677 | 10360575 | A316L2 | Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nDer p 2 |
30 | 00630414970653 | 10360573 | A3050L2 | Aspergillus restrictus-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ nAsp r 1 |
31 | 00630414970103 | 10381630 | LKT31 | T3 Total - IMMULITE - RGT - 100 Tests | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | IMMULITE®/IMMULITE® 1000 Systems T3 Total T3 |
32 | 00630414969343 | 10385667 | E82L4 | Rabbit Epithelium-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Rabbit Epithelium |
33 | 00630414966298 | 10381425 | LKGB1 | IGF BP3 - IMMULITE - RGT - 100 Tests | CFL | RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE | 1 | IMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 |
34 | 00630414966137 | 10380867 | LKIE1 | IgE - IMMULITE - RGT - 100 Tests | JHR | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) | 2 | IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE |
35 | 00630414965925 | 10386023 | M207L2 | Aspergillus -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Aspergillus niger |
36 | 00630414965680 | 10385960 | I70L2 | Imported Fire Ant -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Imported Fire Ant |
37 | 00630414965598 | 10385718 | F214L2 | Spinach-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Spinach |
38 | 00630414965567 | 10385726 | F221L2 | Coffee-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Coffee |
39 | 00630414965437 | 10386151 | W2L2 | Western Ragweed -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Western Ragweed |
40 | 00630414965383 | 10386131 | W10L2 | Lamb#s Quarters -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Lambs Quarters |
41 | 00630414965376 | 10386130 | TP9L4 | Tree Panel 9 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 9 |
42 | 00630414965369 | 10386128 | TP7L4 | Tree Panel 7 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 7 |
43 | 00630414965352 | 10386126 | TP6L4 | Tree Panel 6 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 6 |
44 | 00630414965338 | 10386122 | TP4L4 | Tree Panel 4 - IMMULITE - RGT - 40 test | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Tree Panel 4 |
45 | 00630414965154 | 10386057 | T11L2 | Sycamore -Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Sycamore |
46 | 00630414965079 | 10386042 | M6L4 | Alternaria tenuis-Specific IgE - IMMULITE - RGT | DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 2 | IMMULITE®2000 Systems 3gAllergy™ Alternaria tenuis |
47 | 00630414964874 | 10380900 | LKVB1 | Vitamin B12 - IMMULITE - RGT - 100 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 |
48 | 00630414964607 | 10381628 | LKRT5 | TSH - IMMULITE - RGT - 500 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | 2 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH |
49 | 00630414964591 | 10381637 | LKRT1 | TSH - IMMULITE - RGT - 100 Tests | JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | 2 | IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH |
50 | 00630414964331 | 10380969 | LKOP1 | CA 125 - IMMULITE - RGT - 100 Tests | LTK | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) | 2 | IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 | |
2 | 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 | |
3 | 50192253013717 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
4 | 50192253012239 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
5 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | QuickVue | QUIDEL CORPORATION |
6 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | QuickVue | QUIDEL CORPORATION |
7 | 20885380183642 | CH25 | CH25 | CH25 Cardinal Health H. pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
8 | 20885380163583 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
9 | 20885380163576 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
10 | 20885380020282 | B1077-25 | B1077-25 | H.pylori Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
11 | 15099590625924 | 395160 | 395160 | ICON HP (30 Tests) | Icon | BECKMAN COULTER, INC. |
12 | 10815845020079 | 01P53-25 | Signify® | ALERE SAN DIEGO, INC. | ||
13 | 10815845020048 | 92405 | Clearview® | ALERE SAN DIEGO, INC. | ||
14 | 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. | |
15 | 10796918001839 | 05-9475 | INSTANT-VIEW H. pylori Rapid Test | INSTANT-VIEW H. pylori Rapid Test | ALFA SCIENTIFIC DESIGNS, INC. | |
16 | 10796918001822 | 05-9473 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
17 | 10796918001815 | 05-9472 | INSTANT-VIEW H. Pylori Serum Cassette Test | INSTANT-VIEW H. Pylori Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
18 | 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 | |
19 | 10743816001591 | BSP-406WB-25-02 | Status™ H. pylori card; 25 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
20 | 10743816001584 | BSP-406WB-10-02 | Status™ H. pylori card; 10 Test kit | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | |
21 | 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 |
22 | 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 |
23 | 10743816001140 | BSP-406WB-10-01 | BSP-406WB-10-01 | BioSign® H. pylori card; 10 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
24 | 10743816001133 | BSP-406WB-35-01 | BSP-406WB-35-01 | BioSign® H. pylori card; 35 Test kit; CE | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION |
25 | 10722355002023 | IHP-30 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
26 | 10722355002016 | IHP-10 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | Detector H. pylori | IMMUNOSTICS COMPANY, INC | |
27 | 10304040155742 | 5702778 | 5702778 | Henry Schein One Step + H. Pylori | Henry Schein | HENRY SCHEIN, INC. |
28 | 10304040024154 | 9004071 | 9004071 | One Step + H Pylori Test | Henry Schein | HENRY SCHEIN, INC. |
29 | M220P0800953 | P080095 | P080095 | PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
30 | 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 |
31 | 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 |
32 | 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. | |
33 | 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. | |
34 | 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. | |
35 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
36 | 05391516748827 | 1206650 | 1206650 | Uni-Gold™ H. pylori Antigen, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
37 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
38 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
39 | 05391516747714 | 40-1006 | 40-1006 | EIA Color Developer, 13.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
40 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
41 | 05391516743686 | 2326430 | 2326430 | Captia™ H. pylori IgA | Trinity Biotech | CLARK LABORATORIES, INC. |
42 | 05391516743679 | 2346400 | 2346400 | Captia™ H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
43 | 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 | |
44 | 00893029002571 | GIS-62-2ML | GIS-62-2ML | Urease Glycerol Solution | Urease | GI SUPPLY, INC. |
45 | 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. |
46 | 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. |
47 | 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. | |
48 | 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. | |
49 | 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. | |
50 | 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. |