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.

The Access NT
ACCESS NT-proBNP CALIBRATORS - C71978

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1150

Third Party Flag: N

Medical Specialty: CH

Device Id: 15099590760830

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A