| Primary Device ID | 03573026035600 |
| NIH Device Record Key | 95dfc69c-13f7-4b62-a6de-5f2354a05274 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | API® NH |
| Version Model Number | 10400 |
| Company DUNS | 276816717 |
| Company Name | BIOMERIEUX SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026035600 [Primary] |
| JTO | DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-20 |
| Device Publish Date | 2020-04-10 |
| 03573026256685 - ETEST® Gentamicin (GM) | 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
| 03573026376604 - ETEST® Amoxicillin (AC) | 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
| 03573026377731 - ETEST® Flucytosine (FC) | 2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions |
| 03573026560690 - ETEST® Meropenem/Vaborbactam (MEV) | 2024-04-15 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an |
| 03573026475352 - ETEST® Telavancin (TLA) | 2024-04-12 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
| 03573026252526 - ETEST® Cefepime (PM) | 2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
| 03573026253219 - Etest® TIC/CLAV-CON2 | 2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
| 03573026617851 - VITEK®MS | 2024-03-18 VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument |