| Primary Device ID | 04251204328285 |
| NIH Device Record Key | fdb35234-0089-4d4d-9101-ba7ab9d909d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MBT HT Sepsityper CA Module |
| Version Model Number | 1892646 |
| Company DUNS | 318387958 |
| Company Name | Bruker Daltonik GmbH |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com | |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04251204328285 [Primary] |
| QBN | Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-11-28 |
| 04251204328278 - MBT Compass HT CA | 2025-12-08 |
| 04251204328285 - MBT HT Sepsityper CA Module | 2025-12-08 |
| 04251204328285 - MBT HT Sepsityper CA Module | 2025-12-08 |
| 04251204328728 - MBT FAST Shuttle US IVD | 2025-12-08 |
| 04251204326182 - MBT Sepsityper Kit US IVD | 2021-02-19 Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA |
| 04251204326298 - MBT Galaxy System - US IVD | 2021-02-19 Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for clinical use in USA |
| 04251204326304 - MBT Pilot System - US IVD | 2021-02-19 Visual support for manual sample preparation for use with MBT-CA System, for clinical use in USA |
| 04251204326175 - MALDI Biotyper-BD sirius CA System | 2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser. |
| 04251204326311 - MALDI Biotyper sirius one CA System | 2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser. |