No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04251204325772 | 1840380 | 1840380 | Disposable Ceramic Target | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | MBT Biotarget 96 US IVD | |
2 | 04251204325734 | 8604784 | 8604784 | Biotyper system for clinical use in the USA, with smartbeam laser. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MALDI Biotyper - smart CA |
3 | 04251204326175 | 1890133 | 1890133 | Biotyper system for clinical use in the USA, with smartbeam laser. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MALDI Biotyper-BD sirius CA System |
4 | 04251204326304 | 1875058 | 1875058 | Visual support for manual sample preparation for use with MBT-CA System, for cli Visual support for manual sample preparation for use with MBT-CA System, for clinical use in USA | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MBT Pilot System - US IVD |
5 | 04251204326311 | 1890232 | 1890232 | Biotyper system for clinical use in the USA, with smartbeam laser. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MALDI Biotyper sirius one CA System |
6 | 04251204325666 | 8604532 | 8604532 | Reuseable Stainless Steel Target. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | US IVD 48 Spot Target |
7 | 04251204325659 | 8604531 | 8604531 | HCCA Matrix, 10 tubes | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | US IVD-HCCA Matrix, Portioned 10 Tubes | |
8 | 04251204326182 | 1867565 | 1867565 | Preparation kit for positive blood cultures in conjunction with MBT-CA System, f Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MBT Sepsityper Kit US IVD |
9 | 04251204326298 | 1875054 | 1875054 | Workstation to disperse reagents onto clinical samples for use with MBT-CA Syste Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for clinical use in USA | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MBT Galaxy System - US IVD |
10 | 04251204325642 | 8604530 | 8604530 | Bacterial Test Standard, 5 tubes. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | US IVD-Bruker Bacterial Test Standard, 5 Tubes | |
11 | 04251204326168 | 1890132 | 1890132 | Biotyper system for clinical use in the USA, with smartbeam laser. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MALDI Biotyper sirius CA System |
12 | 04251204326359 | 1890233 | 1890233 | Biotyper system for clinical use in the USA, with smartbeam laser. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MALDI Biotyper-BD sirius one CA System |
13 | 04251204325710 | 8604736 | 8604736 | Biotyper system for clinical use in the USA, for Becton Dickinson. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MBT-CA System BD |
14 | 04251204300014 | 8603464 | 8603464 | Biotyper system for clinical use in the USA. | PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | 2 | MALDI Biotyper CA System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10841594110099 | 8604530 | 8604530 | Bacterial Test Standard, 5 tubes. | US IVD-Bruker Bacterial Test Standard, 5 Tubes | BRUKER SCIENTIFIC LLC |
2 | 10841594110013 | 8604531 | 8604531 | HCCA Matrix, 10 tubes | US IVD-HCCA Matrix, Portioned 10 Tubes | BRUKER SCIENTIFIC LLC |
3 | 04251204326359 | 1890233 | 1890233 | Biotyper system for clinical use in the USA, with smartbeam laser. | MALDI Biotyper-BD sirius one CA System | BRUKER DALTONIK GMBH |
4 | 04251204326311 | 1890232 | 1890232 | Biotyper system for clinical use in the USA, with smartbeam laser. | MALDI Biotyper sirius one CA System | BRUKER DALTONIK GMBH |
5 | 04251204326304 | 1875058 | 1875058 | Visual support for manual sample preparation for use with MBT-CA System, for cli Visual support for manual sample preparation for use with MBT-CA System, for clinical use in USA | MBT Pilot System - US IVD | BRUKER DALTONIK GMBH |
6 | 04251204326298 | 1875054 | 1875054 | Workstation to disperse reagents onto clinical samples for use with MBT-CA Syste Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for clinical use in USA | MBT Galaxy System - US IVD | BRUKER DALTONIK GMBH |
7 | 04251204326182 | 1867565 | 1867565 | Preparation kit for positive blood cultures in conjunction with MBT-CA System, f Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA | MBT Sepsityper Kit US IVD | BRUKER DALTONIK GMBH |
8 | 04251204326175 | 1890133 | 1890133 | Biotyper system for clinical use in the USA, with smartbeam laser. | MALDI Biotyper-BD sirius CA System | BRUKER DALTONIK GMBH |
9 | 04251204326168 | 1890132 | 1890132 | Biotyper system for clinical use in the USA, with smartbeam laser. | MALDI Biotyper sirius CA System | BRUKER DALTONIK GMBH |
10 | 04251204325789 | 1852132 | 1852132 | HCCA Matrix 10 Tubes | US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each | BRUKER DALTONIK GMBH |
11 | 04251204325772 | 1840380 | 1840380 | Disposable Ceramic Target | MBT Biotarget 96 US IVD | BRUKER DALTONIK GMBH |
12 | 04251204325734 | 8604784 | 8604784 | Biotyper system for clinical use in the USA, with smartbeam laser. | MALDI Biotyper - smart CA | BRUKER DALTONIK GMBH |
13 | 04251204325710 | 8604736 | 8604736 | Biotyper system for clinical use in the USA, for Becton Dickinson. | MBT-CA System BD | BRUKER DALTONIK GMBH |
14 | 04251204325666 | 8604532 | 8604532 | Reuseable Stainless Steel Target. | US IVD 48 Spot Target | BRUKER DALTONIK GMBH |
15 | 04251204325659 | 8604531 | 8604531 | HCCA Matrix, 10 tubes | US IVD-HCCA Matrix, Portioned 10 Tubes | BRUKER DALTONIK GMBH |
16 | 04251204325642 | 8604530 | 8604530 | Bacterial Test Standard, 5 tubes. | US IVD-Bruker Bacterial Test Standard, 5 Tubes | BRUKER DALTONIK GMBH |
17 | 04251204300014 | 8603464 | 8603464 | Biotyper system for clinical use in the USA. | MALDI Biotyper CA System | BRUKER DALTONIK GMBH |
18 | 03573026621698 | VITEK MS SW V1.1 | VITEK MS SW V1.1 + KB 3.2 | VITEK®MS | BIOMERIEUX SA | |
19 | 03573026610418 | VITEKMS SW v1.0 / FlexPrep v1.0 | DVD to install VITEK MS SW v1.0 and VITEK MS FlexPrep v1.0 for clinical customers | VITEK®MS | BIOMERIEUX SA | |
20 | 03573026556662 | VITEK® MS CHCA | The VITEK MS-CHCA matrix is used with the VITEK® MS System to enable identificat The VITEK MS-CHCA matrix is used with the VITEK® MS System to enable identification of microorganisms. The matrix absorbs energy from the VITEK MS laser and transfers it to the microorganisms | VITEK® MS CHCA | BIOMERIEUX SA | |
21 | 03573026555559 | VITEK® MS-FA | VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification ac VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used exclusively with the VITEK ® MS instrument. | VITEK® MS-FA | BIOMERIEUX SA | |
22 | 03573026554224 | VITEK® MS-DS | Target slide used for running samples on the VITEK MS containing 48 spots with 3 Target slide used for running samples on the VITEK MS containing 48 spots with 3 sections of 16 | VITEK® MS-DS | BIOMERIEUX SA | |
23 | 03573026437282 | VITEK® MS MOULD KIT | The VITEK® MS MOULD KIT provides the reagents and consumables needed to process The VITEK® MS MOULD KIT provides the reagents and consumables needed to process samples by protein extraction and inactivation for mould identification from agar plates by the VITEK® MS System. | VITEK® MS MOULD KIT | BIOMERIEUX SA | |
24 | 03573026436971 | VITEK® MS MYCOBACTERIUM/NOCARDIA KIT | The VITEK ® MS MYCOBACTERIUM/NOCARDIA KIT provides the reagents and consumables The VITEK ® MS MYCOBACTERIUM/NOCARDIA KIT provides the reagents and consumables needed to process samples by protein extraction and inactivation for Mycobacterium Nocardia identification by VITEK | VITEK® MS MYCOBACTERIUM/NOCARDIA KIT | BIOMERIEUX SA | |
25 | 03573026359119 | 410895 | MALDI-Tof Mass Spectrometry system used for microbial identification | VITEK® MS | BIOMERIEUX SA | |
26 | 03573026328573 | 27210 | Cassette docking station needed for preparing sample loading in the VITEK 2 system | VITEK® MS | BIOMERIEUX , INC. | |
27 | 00841594110054 | 8604532 | 8604532 | Reuseable Stainless Steel Target. | US IVD 48 Spot Target | BRUKER SCIENTIFIC LLC |
28 | 00841594110047 | 8605214 | 8605214 | Biotyper system for clinical use in the USA with smart laser, for Becton Dickson. | BD Bruker MBT smart CA System | BRUKER SCIENTIFIC LLC |
29 | 00841594110030 | 8604736 | 8604736 | Biotyper system for clinical use in the USA, for Becton Dickinson. | MBT-CA System BD | BRUKER SCIENTIFIC LLC |
30 | 00841594100031 | 8604784 | 8604784 | Biotyper system for clinical use in the USA, with smart laser. | MALDI Biotyper - smart CA | BRUKER SCIENTIFIC LLC |
31 | 00841594100024 | 8603464 | 8603464 | Biotyper system for clinical use in the USA. | MALDI Biotyper CA System | BRUKER SCIENTIFIC LLC |