Elecsys proBNP II STAT Immunoassay 09315276160

GUDID 07613336191576

proBNP G2 STAT Elecsys cobas e 100 V2.1

Roche Diagnostics GmbH

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336191576
• NIH Device Record Key: 90e0afb8-4cfa-4763-9066-642e1967990e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys proBNP II STAT Immunoassay
• Version Model Number: 09315276160
• Catalog Number: 09315276160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336191576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210546

FDA Product Code

• NBC: Test, natriuretic peptide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-07

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