No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 20885380190923 | TRUBREZ | TRUBREZ | Quilted TRUBREZ Premium Underpad, Maximum | KME | BEDDING, DISPOSABLE, MEDICAL | (Design) Cardinal Wings | |
2 | 20885380174305 | 8899EC | 8899EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
3 | 20885380174299 | 8898EC | 8898EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
4 | 20885380174282 | 8897EC | 8897EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
5 | 20885380174275 | 8896EC | 8896EC | Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
6 | 20885380166348 | 88FS06XXL | 88FS06XXL | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
7 | 20885380166331 | 88FS05XL | 88FS05XL | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
8 | 20885380166324 | 88FS04L | 88FS04L | Nitrile Exam Gloves Flexal Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
9 | 20885380166317 | 88FS03M | 88FS03M | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
10 | 20885380166300 | 88FS02S | 88FS02S | Nitrile Exam Gloves Flexal Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
11 | 20885380166294 | 88FS01XS | 88FS01XS | Nitrile Exam Gloves Flexal Comfort | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
12 | 20885380163965 | 88ES06XXL | 88ES06XXL | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
13 | 20885380163958 | 88ES05XL | 88ES05XL | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
14 | 20885380163941 | 88ES04L | 88ES04L | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
15 | 20885380163934 | 88ES03M | 88ES03M | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
16 | 20885380163927 | 88ES02S | 88ES02S | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
17 | 20885380163910 | 88ES01XS | 88ES01XS | Nitrile Exam Gloves ESTEEM Comfort | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | ESTEEM | |
18 | 20885380161268 | 88RTF06XXL | 88RTF06XXL | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
19 | 20885380161251 | 88RTF05XL | 88RTF05XL | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
20 | 20885380161244 | 88RTF04L | 88RTF04L | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
21 | 20885380161237 | 88RTF03M | 88RTF03M | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
22 | 20885380161220 | 88RTF02S | 88RTF02S | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
23 | 20885380161213 | 88RTF01XS | 88RTF01XS | NITRILE EXAM GLOVES FLEXAL TOUCH W DISPENSING FILM | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
24 | 20885380157384 | 88RT06XXL | 88RT06XXL | NITRILE EXAM GLOVES FLEXAL TOUCH | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
25 | 20885380157377 | 88RT05XL | 88RT05XL | NITRILE EXAM GLOVES FLEXAL TOUCH | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
26 | 20885380157360 | 88RT04L | 88RT04L | NITRILE EXAM GLOVES FLEXAL TOUCH | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
27 | 20885380157353 | 88RT03M | 88RT03M | NITRILE EXAM GLOVES FLEXAL TOUCH | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
28 | 20885380157346 | 88RT02S | 88RT02S | NITRILE EXAM GLOVES FLEXAL TOUCH | LZA,LZC | Polymer patient examination glove,Patient examination glove, specialty | FLEXAL | |
29 | 20885380157339 | 88RT01XS | 88RT01XS | NITRILE EXAM GLOVES FLEXAL TOUCH | LZC,LZA | Patient examination glove, specialty,Polymer patient examination glove | FLEXAL | |
30 | 20885380137157 | 88TN05XL | 88TN05XL | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
31 | 20885380140959 | 88TNF06XXL | 88TNF06XXL | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
32 | 20885380140942 | 88TNF05XL | 88TNF05XL | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
33 | 20885380140935 | 88TNF04L | 88TNF04L | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
34 | 20885380140881 | 88TNF03M | 88TNF03M | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
35 | 20885380140850 | 88TNF02S | 88TNF02S | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
36 | 20885380140843 | 88TNF01XS | 88TNF01XS | Nitrile Exam Gloves Flexal w Dispensing Film | LZA | Polymer patient examination glove | FLEXAL | |
37 | 20885380137164 | 8815NB | 8815NB | Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves | LZA | Polymer patient examination glove | ESTEEM | |
38 | 20885380137133 | 88TN04L | 88TN04L | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
39 | 20885380137126 | 88TN03M | 88TN03M | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
40 | 20885380137119 | 88TN02S | 88TN02S | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
41 | 20885380137102 | 88TN01XS | 88TN01XS | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
42 | 20885380137096 | 88TN06XXL | 88TN06XXL | Nitrile Exam Gloves Flexal | LZA | Polymer patient examination glove | FLEXAL | |
43 | 20885380135528 | 8884DOTP | 8884DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
44 | 20885380135511 | 8883DOTP | 8883DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
45 | 20885380135504 | 8882DOTP | 8882DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
46 | 20885380135498 | 8881DOTP | 8881DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
47 | 20885380135481 | 8880DOTP | 8880DOTP | Vinyl Exam Gloves | LYZ | Vinyl patient examination glove | ESTEEM | |
48 | 20885380135436 | S88RX05 | S88RX05 | Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restor Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes | LYZ | Vinyl patient examination glove | ESTEEM | |
49 | 20885380135429 | S88RX04 | S88RX04 | Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restor Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes | LYZ | Vinyl patient examination glove | ESTEEM | |
50 | 20885380135412 | S88RX03 | S88RX03 | Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restor Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes | LYZ | Vinyl patient examination glove | ESTEEM |
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. |