MBT Sepsityper Kit US IVD

Basic Information

• Brand Name: MBT Sepsityper Kit US IVD
• Primary DI: 04251204326182
• Version / Model: 1867565
• Catalog Number: 1867565
• Company Name: Bruker Daltonik GmbH
• Labeler DUNS: 318387958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-11
• Public Version: 3
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: b6ced8f8-3a2d-4f39-ac17-962ad3be146d

Device Description

Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEX	System, mass spectrometry, maldi tof, microorganism identification, cultured isolates	Microbiology	866.3361	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61336	Mass spectrometry analysis specimen preparation kit IVD	A collection of reagents and other associated materials intended to be used in the preparation of a previously processed clinical specimen (e.g., nucleic acids, proteins) for mass spectrometry analysis (e.g., electrospray ionization, MALDI-TOF). It typically consists of organic/inorganic compound solutions (e.g., imidazole, ammonium bicarbonate) that may added to a volatile solution (e.g., methanol, acetonitrile, hexane) to enable the specimen to disperse into a fine aerosol, and/or promote ionisation of the analyte. The kit can be used with manual or automated instruments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251204326182	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep the MBT Sepsityper Kit US IVD components out of direct sunlight
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit