Bruker Daltonik GmbH

Address:Fahrenheitstrasse 4,Bremen,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, mass spectrometry, maldi tof, microorganism identification, cultured isolates (PEX) (10)

Premarket Exempt

Clear

MALDI Biotyper CA System - 04251204300014 Catalog Number : 8603464

Device Description : Biotyper system for clinical use in the USA.

Device Class : 2

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

US IVD-Bruker Bacterial Test Standard, 5 Tubes - 04251204325642 Catalog Number : 8604530

Device Description : Bacterial Test Standard, 5 tubes.

Device Class :

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 5

US IVD-HCCA Matrix, Portioned 10 Tubes - 04251204325659 Catalog Number : 8604531

Device Description : HCCA Matrix, 10 tubes

Device Class :

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 10

US IVD 48 Spot Target - 04251204325666 Catalog Number : 8604532

Device Description : Reuseable Stainless Steel Target.

Device Class : 2

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

MBT-CA System BD - 04251204325710 Catalog Number : 8604736

Device Description : Biotyper system for clinical use in the USA, for Becton Dickinson.

Device Class : 2

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

MALDI Biotyper - smart CA - 04251204325734 Catalog Number : 8604784

Device Description : Biotyper system for clinical use in the USA, with smartbeam laser.

Device Class : 2

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

MBT Biotarget 96 US IVD - 04251204325772 Catalog Number : 1840380

Device Description : Disposable Ceramic Target

Device Class :

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 20

US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each - 04251204325789 Catalog Number : 1852132

Device Description : HCCA Matrix 10 Tubes

Device Class :

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 10

MALDI Biotyper sirius CA System - 04251204326168 Catalog Number : 1890132

Device Description : Biotyper system for clinical use in the USA, with smartbeam laser.

Device Class : 2

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

MALDI Biotyper-BD sirius CA System - 04251204326175 Catalog Number : 1890133

Device Description : Biotyper system for clinical use in the USA, with smartbeam laser.

Device Class : 2

Duns Number: 318387958

Premarket Exempt : No

Product Code : PEX

Prescription Use : Yes

Device Count : 1

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