US IVD-HCCA Matrix, Portioned 10 Tubes 8604531

GUDID 04251204325659

HCCA Matrix, 10 tubes

Bruker Daltonik GmbH

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

• Primary Device ID: 04251204325659
• NIH Device Record Key: 2cfbdcb4-cda7-42f3-bec5-800986aa1298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US IVD-HCCA Matrix, Portioned 10 Tubes
• Version Model Number: 8604531
• Catalog Number: 8604531
• Company DUNS: 318387958
• Company Name: Bruker Daltonik GmbH
• Device Count: 10
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Min stability 2 years.
• Special Storage Condition, Specify: Between 0 and 0 *Max 8hr working time unrefridgerated.
• Handling Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251204325659 [Primary]
GS1	04251204325765 [Unit of Use]

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: 4
• Public Version Date: 2018-10-05
• Device Publish Date: 2017-02-25

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• 04251204325659 - US IVD-HCCA Matrix, Portioned 10 Tubes: 2018-10-05HCCA Matrix, 10 tubes
• 04251204325659 - US IVD-HCCA Matrix, Portioned 10 Tubes: 2018-10-05 HCCA Matrix, 10 tubes