| Primary Device ID | 10673486013993 |
| NIH Device Record Key | 50c146dc-5a26-4ac4-9a95-3e2bd41efc60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test |
| Version Model Number | F735-25 |
| Catalog Number | F735-25 |
| 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 | |
| Phone | 7144631111 |
| hello@tecodiagnostics.com | |
| 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 |
| 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 | 10673486013993 [Primary] |
| KHE | Reagent, Occult Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2026-01-30 |
| 10673486013993 - Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test | 2026-02-09Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test is an immune-chromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physician’s offices. |
| 10673486013993 - Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test | 2026-02-09 Teco Diagnostics Rapid Fecal Occult Blood (FOB) Test is an immune-chromatographic assay intended for the determination of human |
| 10673486013986 - Teco Diagnostics H. Pylori Card Test | 2026-02-04 Teco Diagnostics H. Pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies speci |
| 10673486013979 - Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method) | 2026-01-27 Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method) is used for the quantitative determination of alanine am |
| 10673486002478 - GLUCOPAD TC-SMART+ Lancets Kit | 2025-06-18 Each GLUCOPAD TC-SMART+ Lancets Kit has 100 pcs per kit. The intended use is for capillary blood sampling on a patient age 6 mo |
| 10673486013580 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use.The device |
| 10673486013726 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device |
| 10673486013894 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device |
| 10673486013962 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device |