Elecsys proBNP II CalSet 09315292190

GUDID 07613336191538

proBNP G2 CS Elecsys V2.1

Roche Diagnostics GmbH

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

• Primary Device ID: 07613336191538
• NIH Device Record Key: d8d868f3-ae40-4d09-b107-19a24afb9a0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys proBNP II CalSet
• Version Model Number: 09315292190
• Catalog Number: 09315292190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07613336191538 [Primary]

FDA Product Code

• JIT: Calibrator, secondary

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

On-Brand Devices [Elecsys proBNP II CalSet]

• 07613336191552: proBNP G2 CS Elecsys E2G V2.1
• 07613336191538: proBNP G2 CS Elecsys V2.1