| Primary Device ID | 10673486013986 |
| NIH Device Record Key | b33e8afd-ce28-43a3-9ccc-ffba3ea191c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics H. Pylori Card Test |
| Version Model Number | H730-50 |
| Catalog Number | H730-50 |
| Company DUNS | 185067774 |
| Company Name | TECO DIAGNOSTICS |
| 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 | false |
| 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 |
| Phone | 7144631111 |
| hello@tecodiagnostics.com | |
| Phone | 7144631111 |
| hello@tecodiagnostics.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10673486013986 [Primary] |
| LYR | Helicobacter Pylori |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-04 |
| Device Publish Date | 2026-01-27 |
| 10673486002393 | Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative deter |
| 10673486013986 | Teco Diagnostics H. Pylori Card Test is an immunochromatographic assay for the qualitative deter |