| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10722355002139 | HS-340 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen 340 Test | ||
| 2 | 10722355002023 | IHP-30 | Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies | LYR | Helicobacter pylori | Detector H. pylori | ||
| 3 | 10722355001477 | RA-100U | A rapid undiluted latex slide test for the detection of rheumatoid factors | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Detector Lex RA | ||
| 4 | 10722355001514 | RH-100 | A rapid color enhanced hemagglutination slide test for the detection of rheumato A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Detector Rheumacol | ||
| 5 | 10722355001507 | RH-50 | A rapid color enhanced hemagglutination slide test for the detection of rheumato A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Detector Rheumacol | ||
| 6 | 10722355001460 | RA-50U | A rapid undiluted latex slide test for the detection of rheumatoid factors | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Detector Lex RA | ||
| 7 | 10722355001125 | HSDV-8 | Fecal Occult Blood Reagent, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 8 | 10722355001040 | HSPP-50 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 9 | 10722355001033 | HS-34 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 10 | 10722355001026 | HS-1000 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 11 | 10722355001019 | HS-100 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 12 | 10722355001002 | HS-50 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 13 | 10722355002917 | IDU-2GP | For rapid detection of multiple analytes in human urine. | JIL,JIO,LJX,CDM,CEN,JIR,JRE,JIN,JMT,JJB,JMA | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),BLOOD, OCCULT, COLORIMETR METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),BLOOD, OCCULT, COLORIMETRIC, IN URINE,TEST, URINE LEUKOCYTE,DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.),Dye-indicator, pH (urinary, non-quantitative),INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),REFRACTOMETER FOR CLINICAL USE,NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.),DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.),ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC) | Detector UA 2GP | ||
| 14 | 10722355002825 | 2010 | For the qualitative detection of hCG in urine | JHI | Visual, pregnancy hCG, prescription use | To Life HCG Pregnancy Test Strip | ||
| 15 | 10722355002818 | HS-100ND | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen | ||
| 16 | 10722355002245 | IDU-2PG | Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which sever Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed | JIR,JIL | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),METHOD, ENZYMATIC, GL INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | Detector UA 2 | ||
| 17 | 10722355001392 | IDP-100 | For the qualitative detection of hCG in urine | LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Detector hCG Personal | ||
| 18 | 10722355002887 | IDP-25 | Home pregnancy test for early results | LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Detector hCG Personal | ||
| 19 | 00722355002859 | 5050M2-3B | Home pregnancy test for early results | LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Am I Pregnant? | ||
| 20 | 00722355002842 | 5050M2-1B | Home pregnancy test for early results | LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 2 | Am I Pregnant? | |
| 21 | 10722355002054 | IHS-25OR | For the qualitative detection of hCG in urine | JHI | Visual, pregnancy hCG, prescription use | Detector hCG Stick | ||
| 22 | 10722355001330 | IHS-25 | For the qualitative detection of hCG in urine | JHI | Visual, pregnancy hCG, prescription use | Detector hCG Stick | ||
| 23 | 10722355001354 | IHS-100 | For the qualitative detection of hCG in urine | JHI | Visual, pregnancy hCG, prescription use | Detector hCG Stick | ||
| 24 | 10722355001347 | IHS-50 | For the qualitative detection of hCG in urine | JHI | Visual, pregnancy hCG, prescription use | Detector hCG Stick | ||
| 25 | 10722355001194 | CRP-100 | A rapid undiluted latex slide test for the detection of C-Reactive Protein | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | Detector Lex-CRP | ||
| 26 | 10722355001187 | CRP-50 | A rapid undiluted latex slide test for the detection of C-Reactive Protein | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | Detector Lex-CRP | ||
| 27 | 10722355001170 | CRC-100 | A rapid color enhanced latex slide test for the detection of C-Reactive Protein | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | Detector C-Reactacol | ||
| 28 | 10722355001163 | CRC-50 | A rapid color enhanced latex slide test for the detection of C-Reactive Protein | DCN | SYSTEM, TEST, C-REACTIVE PROTEIN | Detector C-Reactacol | ||
| 29 | 10722355003051 | 100-PROMO | 100-PROMO | 1 hemochroma PLUS Analyzer+100 Microcuvettes+1 optical system check | GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | hemochroma PLUS Starter Kit | |
| 30 | 10722355003044 | 100-404 | 100-404 | hemochroma PLUS Optical System Check is intended to assure the performance of th hemochroma PLUS Optical System Check is intended to assure the performance of the optic system of the hemochroma PLUS Analyzer. | GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | 2 | hemochroma PLUS Optical System Check |
| 31 | 10722355001668 | IST-501-OBC33 | IDSTREP-25 | A qualitative immunoassay for the detection of Strep A Antigen from direct throat swab | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | Detector Strep A | |
| 32 | 10722355003037 | 100-303 | 100-303 | hemochroma PLUS Controls are intended for use as quality control material to ass hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS System in measuring the human hemoglobin concentration. | GGM | Control, hemoglobin | hemochroma PLUS Control | |
| 33 | 00722355002873 | 2033 | Home pregnancy test for early results | LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | To Life | ||
| 34 | 00722355002866 | 2030 | Home pregnancy test for early results | LCX | KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 2 | To Life | |
| 35 | 10722355002559 | HSDVER-8 | Fecal Occult Blood Reagent, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen ER developer | ||
| 36 | 10722355002542 | HSTRER-100 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen ER | ||
| 37 | 10722355002528 | HSPP-50ER | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen ER | ||
| 38 | 10722355002535 | HSER-34 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen ER | ||
| 39 | 10722355002511 | HSER-50 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen ER | ||
| 40 | 10722355002504 | HSER-100 | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen ER | ||
| 41 | 10722355001538 | RHLX-100 | A rapid color enhanced undiluted latex slide test for the qualitative or semi- q A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Detector Rheumacol Lex | ||
| 42 | 10722355001521 | RHLX-50 | A rapid color enhanced undiluted latex slide test for the qualitative or semi- q A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum | DHR | SYSTEM, TEST, RHEUMATOID FACTOR | Detector Rheumacol Lex | ||
| 43 | 10722355001446 | 43100 | A rapid latex inhibition slide test for the detection of hCG in urine | JHJ | AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN | Detector Cept-D Polyclonal | ||
| 44 | 10722355003020 | 100-202 | 100-202 | The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concent The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concentration in human whole blood along with the hemochroma PLUS Analyzer. The hemochroma PLUS Microcuvette is inserted into a holder of hemochroma PLUS Analyzer for quantification of hemoglobin in blood | GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | hemochroma PLUS Microcuvettes | |
| 45 | 10722355003013 | 100-101 | 100-101 | The hemochroma PLUS Analyzer calculates the test result automatically and displa The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL. | GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | 2 | hemochroma PLUS Analyzer |
| 46 | 10722355001729 | SLE-100 | A rapid undiluted latex agglutination slide test for the detection of anti-nucle A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE) | DHC | SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS | Detector Lex SLE | ||
| 47 | 10722355001712 | SLE-50 | A rapid undiluted latex agglutination slide test for the detection of anti-nucle A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE) | DHC | SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS | Detector Lex SLE | ||
| 48 | 10722355002221 | IDU-10 | Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which sever Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed | JRE,JIL,JJB,JIN,CDM,JMA,JMT,JIR,CEN,LJX | REFRACTOMETER FOR CLINICAL USE,METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITA REFRACTOMETER FOR CLINICAL USE,METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.),NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.),DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.),ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC),DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),DYE-INDICATOR, PH (URINARY, NON-QUANT.),TEST, URINE LEUKOCYTE | Detector UA 10 | ||
| 49 | 10722355002238 | IDU-5OB | Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which sever Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed | JIO,JIR,LJX,JMT,JIL | BLOOD, OCCULT, COLORIMETRIC, IN URINE,INDICATOR METHOD, PROTEIN OR ALBUMIN (URIN BLOOD, OCCULT, COLORIMETRIC, IN URINE,INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),TEST, URINE LEUKOCYTE,DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | Detector UA 5 | ||
| 50 | 10722355002146 | HSTR-335CS | Fecal Occult Blood IVD, Guaiac | KHE | REAGENT, OCCULT BLOOD | hema-screen Triple 335 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03573026509231 | 30192-01 | VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA). | VIDAS® H. pylori IgG | BIOMERIEUX SA | |
| 2 | 00893029002571 | GIS-62-2ML | GIS-62-2ML | Urease Glycerol Solution | Urease | GI SUPPLY, INC. |
| 3 | 00893029002519 | GIS-22 | GIS-22 | HpFast detects the urease enzyme for the presumptive identification of Helicobac HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. | HpFast | GI SUPPLY, INC. |
| 4 | 00893029002502 | GIS-64 | GIS-64 | HpOne detects the urease enzyme for the presumptive identification of Helicobact HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. | HpOne | GI SUPPLY, INC. |
| 5 | 00857031002639 | T5051B | The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI CHEK | TECHLAB, INC. | |
| 6 | 00857031002622 | 20343 | The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoa The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | QuickVue TLI H. pylori Stool Antigen Test | TECHLAB, INC. | |
| 7 | 00857031002561 | 20343 | The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the q The QuickVue TLI H. pylori Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | QuickVue TLI H. pylori Test | TECHLAB, INC. | |
| 8 | 00857031002523 | 30996 | The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI CHEK | TECHLAB, INC. | |
| 9 | 00857031002516 | 30925 | The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI QUIK CHEK | TECHLAB, INC. | |
| 10 | 00857031002509 | T5051 | The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative d The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI CHEK | TECHLAB, INC. | |
| 11 | 00857031002493 | T5050 | The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay fo The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | H. PYLORI QUIK CHEK | TECHLAB, INC. | |
| 12 | 00855574005414 | HP20 | H. Pylori, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
| 13 | 00850487007654 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. | |
| 14 | 00850487007647 | H. pylori A | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. | |
| 15 | 00850487007531 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
| 16 | 00850487007159 | H.pylori G | 01550Q-1 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
| 17 | 00840733102271 | 760130 | 760130 | Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluoresce Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. | Curian HpSA | MERIDIAN BIOSCIENCE, INC. |
| 18 | 00840733101779 | 710030 | 710030 | The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative pro The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices. | ImmunoCard H. pylori | MERIDIAN BIOSCIENCE, INC. |
| 19 | 00840733101731 | 606096 | 606096 | Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative de Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative detection of IgG antibodies to Helicobacter pylori in human serum and plasma. Test results are intended to aid in the diagnosis of H. pylori infection. | PREMIER H. pylori | MERIDIAN BIOSCIENCE, INC. |
| 20 | 00840733101670 | 601396 | 601396 | The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitati The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. | PREMIER Platinum HpSA PLUS | MERIDIAN BIOSCIENCE, INC. |
| 21 | 00840733101427 | 610190 | 610190 | Curian is an Immunoassay Analyzer designed to automate incubation, results inter Curian is an Immunoassay Analyzer designed to automate incubation, results interpretation and results reporting of immunoassay diagnostic products. Curian is intended for use with Curian fluorescent immunoassay products. Curian-compatible Meridian Bioscience products are described in individual immunoassay package inserts. | Curian Analyzer | MERIDIAN BIOSCIENCE, INC. |
| 22 | 00840733101380 | 750220 | 750220 | The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the dete The ImmunoCard STAT! HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. | ImmunoCard STAT! HpSA | MERIDIAN BIOSCIENCE, INC. |
| 23 | 00817273020037 | 300-331A | 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit | Diamedix | DIAMEDIX CORPORATION | |
| 24 | 00816870022741 | 1475-300 | 1475-300A | Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells | MONOBIND, INC. | |
| 25 | 00816870022734 | 1575-300 | 1575-300A | Monobind AccuLite Anti-H. Pylori IgG CLIA Kit - 96 Wells | MONOBIND, INC. | |
| 26 | 00816870022727 | 1675-300 | 1675-300A | Monobind AccuLite Anti-H. Pylori IgA CLIA Kit - 96 Wells | MONOBIND, INC. | |
| 27 | 00816870021102 | 1425-300 | 1425-300A | Monobind AccuBind Anti-H. Pylori IgM ELISA Kit - 96 Wells | MONOBIND, INC. | |
| 28 | 00816870021096 | 1525-300 | 1525-300A | Monobind AccuBind Anti-H. Pylori IgG ELISA Kit - 96 Wells | MONOBIND, INC. | |
| 29 | 00816870021089 | 1625-300 | 1625-300A | Monobind AccuBind Anti-H. Pylori IgA ELISA Kit - 96 Wells | MONOBIND, INC. | |
| 30 | 00742860100161 | 175 | 175 | OSOM H Pylori 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 31 | 00722066000304 | HPY-13C15 | HPY-13C15 | Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma. | Rapid Response | BTNX INC |
| 32 | 00695684330200 | 33020 | A rapid cassette test for the qualitative detection of Helicobabacter pylori in A rapid cassette test for the qualitative detection of Helicobabacter pylori in serum, plasma, or whole blood. | AIMSTEP H. PYLORI | GERMAINE LABORATORIES, INC | |
| 33 | 00657498000014 | 6300-020 | 6300-020 | For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. | RELY® H.Pylori | STANBIO LABORATORY, L.P. |
| 34 | 00630414989907 | 10469596 | LHPGCM | H.Pylori - IMMULITE - CTL | IMMULITE® Systems HPG CONTROL H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 35 | 00630414964164 | 10381272 | LKHPG1 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 36 | 00630414961644 | 10381335 | L2KHPG6 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 37 | 00630414961637 | 10381336 | L2KHPG2 | Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems HPG H.pylori IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 38 | 00630414960944 | 10385353 | L1KIDW1 | Infectious Disease Diluent - IMMULITE - CAL | IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 39 | 00613647000519 | 4581465021 | 23900535 | SURE-VUE H. PYLORI 30/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 40 | 00612479202719 | 5007 | TEST KIT, H PYLORI (10/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 41 | 00612479202702 | 5008 | TEST KIT, H PYLORI (25/KT) | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 42 | 00350770927459 | 92745 | 60480 | AVANOS* CLOTEST* Rapid Urease Test | AVANOS | AVANOS MEDICAL, INC. |
| 43 | 00350770926636 | 92663 | 60407 | HALYARD* CLOTEST* Jack Bean Urease Control Tablets | AVANOS | AVANOS MEDICAL, INC. |
| 44 | 00083059070040 | 7004 | The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antib The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori. | GAP®-IgG (Gastritis and Peptic Ulcer Test) | BIOMERICA, INC. | |
| 45 | B350GSD0110010 | GSD01-1001 | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
| 46 | B350GSD0110000 | GSD01-1000 | Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit | Gold Standard Diagnostics H. pylori ELISA IgG Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
| 47 | 50192253013717 | 1077-25EIA | 1077-25EIA | H. pylori Stool Antigen ELISA Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 48 | 50192253012239 | B1077-25CH | B1077-25CH | H. pylori Stool Antigen Rapid Test Kit | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 49 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | QuickVue | QUIDEL CORPORATION |
| 50 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | QuickVue | QUIDEL CORPORATION |