US IVD-Bruker Bacterial Test Standard, 5 Tubes 8604530

GUDID 10841594110099

Bacterial Test Standard, 5 tubes.

BRUKER DALTONICS INC.

Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD

• Primary Device ID: 10841594110099
• NIH Device Record Key: 358d1eca-4036-4ed6-8647-e628960b9465
• Commercial Distribution Discontinuation: 2019-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: US IVD-Bruker Bacterial Test Standard, 5 Tubes
• Version Model Number: 8604530
• Catalog Number: 8604530
• Company DUNS: 877298661
• Company Name: BRUKER DALTONICS INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com
• Phone: +1(877)442-2231
• Email: ms.support.us@bruker.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Special Storage Condition, Specify: Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841594110092 [Unit of Use]
GS1	10841594110099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130831

FDA Product Code

• PEX: System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-25
• Device Publish Date: 2016-09-16

Devices Manufactured by BRUKER DALTONICS INC.

• 00841594100024 - MALDI Biotyper CA System: 2020-02-25 Biotyper system for clinical use in the USA.
• 00841594100031 - MALDI Biotyper - smart CA: 2020-02-25 Biotyper system for clinical use in the USA, with smart laser.
• 00841594110030 - MBT-CA System BD: 2020-02-25 Biotyper system for clinical use in the USA, for Becton Dickinson.
• 00841594110047 - BD Bruker MBT smart CA System: 2020-02-25 Biotyper system for clinical use in the USA with smart laser, for Becton Dickson.
• 10841594110020 - US IVD 48 Spot Target: 2020-02-25 Reuseable Stainless Steel Target.
• 10841594110013 - US IVD-HCCA Matrix, Portioned 10 Tubes: 2020-02-25 HCCA Matrix, 10 tubes
• 10841594110099 - US IVD-Bruker Bacterial Test Standard, 5 Tubes: 2020-02-25Bacterial Test Standard, 5 tubes.
• 10841594110099 - US IVD-Bruker Bacterial Test Standard, 5 Tubes: 2020-02-25 Bacterial Test Standard, 5 tubes.