| Primary Device ID | 00857031002325 |
| NIH Device Record Key | 58823104-4221-4226-b978-04b1c67d0417 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASCA-CHEK |
| Version Model Number | T5016 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857031002325 [Primary] |
| NBT | Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-20 |
| 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 | 2019-10-04 The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobact |