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

Devices Manufactured by Beckman Coulter, Inc.

• 15099590806255 - ACCESS HBsAg: 2026-01-26 The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of hepati
• 15099590806262 - ACCESS HBsAg Confirmatory: 2026-01-26 The Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confir
• 15099590806279 - Access HBsAg CALIBRATOR: 2026-01-26 The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays for the in vitro qual
• 15099590806286 - ACCESS HBsAg QC: 2026-01-26 The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAg Confirmatory assays. The
• 15099590806415 - ACCESS anti-HAV: 2026-01-26 The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of tot
• 15099590806422 - ACCESS anti-HAV CALIBRATOR: 2026-01-26 The Access anti-HAV Calibrator is intended to calibrate the Access anti-HAV assay for the in vitro qualitative detection of anti
• 15099590806439 - ACCESS anti-HAV QC: 2026-01-26 The Access anti-HAV QC is intended for monitoring system performance of the Access anti-HAV assay. The Access anti-HAV QC is for
• 15099590799717 - MicroScan: 2025-12-25 MicroScan LabPro V5.03 System (US), Electronic