Bruker Scientific LLC

Address:40 Manning Rd,Billerica,MA,01821,US

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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) (7)

Premarket Exempt

Clear

MALDI Biotyper CA System - 00841594100024 Catalog Number : 8603464

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

Device Class : 2

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 1

MALDI Biotyper - smart CA - 00841594100031 Catalog Number : 8604784

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

Device Class : 2

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 1

MBT-CA System BD - 00841594110030 Catalog Number : 8604736

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

Device Class : 2

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 1

BD Bruker MBT smart CA System - 00841594110047 Catalog Number : 8605214

Device Description : Biotyper system for clinical use in the USA with smart laser, for Becton Dickson.

Device Class : 2

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 1

US IVD 48 Spot Target - 00841594110054 Catalog Number : 8604532

Device Description : Reuseable Stainless Steel Target.

Device Class : 2

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 1

US IVD-HCCA Matrix, Portioned 10 Tubes - 10841594110013 Catalog Number : 8604531

Device Description : HCCA Matrix, 10 tubes

Device Class :

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 10

US IVD-Bruker Bacterial Test Standard, 5 Tubes - 10841594110099 Catalog Number : 8604530

Device Description : Bacterial Test Standard, 5 tubes.

Device Class :

Duns Number: 877298661

Premarket Exempt : No

Product Code : PEX

Prescription Use : No

Device Count : 5

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