ACCESS NT-proBNP CALIBRATORS C71978

GUDID 15099590760830

The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the DxI Access Immunoassay Analyzers.

Beckman Coulter, Inc.

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

• Primary Device ID: 15099590760830
• NIH Device Record Key: 2ee251c3-55e7-406f-a04b-e19493ce86fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS NT-proBNP CALIBRATORS
• Version Model Number: C71978
• Catalog Number: C71978
• 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	15099590760830 [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: 2024-04-29
• Device Publish Date: 2024-04-19

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