Access BNP QC 98201

GUDID 15099590750954

The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems.

Beckman Coulter, Inc.

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

• Primary Device ID: 15099590750954
• NIH Device Record Key: 34194119-6303-4164-b39f-e365f04c3ae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access BNP QC
• Version Model Number: 98201
• Catalog Number: 98201
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	15099590750954 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2021-08-26
• Device Publish Date: 2021-08-18

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