Primary Device ID | 00857031002622 |
NIH Device Record Key | b8f30c7b-5e4d-40e8-bd3e-8892076cdc8e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | QuickVue TLI H. pylori Stool Antigen Test |
Version Model Number | 20343 |
Company DUNS | 614218634 |
Company Name | TECHLAB, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
00857031002646 - C. DIFFICILE TOX A/B II | 2021-05-17 The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains o |
00857031002660 - C. DIFF CHEK - 60 | 2021-05-11 The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glut |
00857031002639 - H. PYLORI CHEK | 2021-03-22 The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific anti |
00857031002066 - C. DIFFICILE TOXIN ANTITOXIN KIT | 2020-02-03 The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for |
00857031002073 - C. DIFFICILE TOX-B TEST | 2020-02-03 The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C |
00857031002264 - C. DIFFICILE TOX-B TEST | 2020-02-03 The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C |
00857031002530 - LEUKO EZ VUE | 2020-02-03 The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, |
00857031002622 - QuickVue TLI H. pylori Stool Antigen Test | 2019-10-04The 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. |
00857031002622 - QuickVue TLI H. pylori Stool Antigen Test | 2019-10-04 The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobact |