US IVD-Bruker Bacterial Test Standard, 5 Tubes

Basic Information

• Brand Name: US IVD-Bruker Bacterial Test Standard, 5 Tubes
• Primary DI: 10841594110099
• Version / Model: 8604530
• Catalog Number: 8604530
• Company Name: Bruker Scientific LLC
• Labeler DUNS: 877298661
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 7
• Public Version Date: 2022-09-26
• Public Version Status: Update
• Public Device Record Key: 358d1eca-4036-4ed6-8647-e628960b9465
• Distribution End Date: 2019-05-31

Device Description

Bacterial Test Standard, 5 tubes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
61954	Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs for the preparation or processing of a clinical specimen for subsequent liquid chromatography and/or mass spectrometry (LC/MS) separation and/or analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841594110099	GS1
Unit of Use	00841594110092	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Max 8hr working time unrefridgerated.
• Type: Special Storage Condition, Specify
• Special Conditions: Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Type: Handling Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -18 – -18 Degrees Celsius