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 | 05391516748834 | 1206651 | 1206651 | Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
2 | 05391516748827 | 1206650 | 1206650 | Uni-Gold™ H. pylori Antigen, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
3 | 05391516747738 | 41-9002 | 41-9002 | Marsorb G, 10.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
4 | 05391516747721 | 40-1013 | 40-1013 | 10x Wash Solution, 100 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
5 | 05391516747714 | 40-1006 | 40-1006 | EIA Color Developer, 13.0 mL | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
6 | 05391516747516 | 2346401 | 2346401 | Captia H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
7 | 05391516743686 | 2326430 | 2326430 | Captia™ H. pylori IgA | Trinity Biotech | CLARK LABORATORIES, INC. |
8 | 05391516743679 | 2346400 | 2346400 | Captia™ H. pylori IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
9 | 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 | |
10 | 00893029002571 | GIS-62-2ML | GIS-62-2ML | Urease Glycerol Solution | Urease | GI SUPPLY, INC. |
11 | 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. |
12 | 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. |
13 | 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. | |
14 | 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. | |
15 | 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. | |
16 | 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. | |
17 | 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. | |
18 | 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. | |
19 | 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. | |
20 | 00855574005414 | HP20 | H. Pylori, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
21 | 00850487007654 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. | |
22 | 00850487007647 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. | |
23 | 00850487007531 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
24 | 00850487007159 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
25 | 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. |
26 | 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. |
27 | 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. |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 00817273020037 | 300-331A | 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit | Diamedix | DIAMEDIX CORPORATION | |
32 | 00816870022741 | 1475-300 | 1475-300A | Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells | MONOBIND, INC. | |
33 | 00816870022734 | 1575-300 | 1575-300A | Monobind AccuLite Anti-H. Pylori IgG CLIA Kit - 96 Wells | MONOBIND, INC. | |
34 | 00816870022727 | 1675-300 | 1675-300A | Monobind AccuLite Anti-H. Pylori IgA CLIA Kit - 96 Wells | MONOBIND, INC. | |
35 | 00816870021102 | 1425-300 | 1425-300A | Monobind AccuBind Anti-H. Pylori IgM ELISA Kit - 96 Wells | MONOBIND, INC. | |
36 | 00816870021096 | 1525-300 | 1525-300A | Monobind AccuBind Anti-H. Pylori IgG ELISA Kit - 96 Wells | MONOBIND, INC. | |
37 | 00816870021089 | 1625-300 | 1625-300A | Monobind AccuBind Anti-H. Pylori IgA ELISA Kit - 96 Wells | MONOBIND, INC. | |
38 | 00742860100161 | 175 | 175 | OSOM H Pylori 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
39 | 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 |
40 | 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 | |
41 | 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. |
42 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | IMMULITE® Systems HPG CONTROL H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
43 | 00630414964164 | 10381272 | LKHPG1 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
44 | 00630414961644 | 10381335 | L2KHPG6 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
45 | 00630414961637 | 10381336 | L2KHPG2 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
46 | 00630414960944 | 10385353 | L1KIDW1 | Infectious Disease Diluent - IMMULITE - CAL | IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
47 | 00613647000519 | 4581465021 | 23900535 | SURE-VUE H. PYLORI 30/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
48 | 00612479202719 | 5007 | TEST KIT, H PYLORI (10/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
49 | 00612479202702 | 5008 | TEST KIT, H PYLORI (25/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
50 | 00350770927459 | 92745 | 60480 | AVANOS* CLOTEST* Rapid Urease Test | AVANOS | AVANOS MEDICAL, INC. |