Access BNP Calibrators 98202

GUDID 15099590750961

The Access BNP Calibrators are intended to calibrate the Access BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

Beckman Coulter, Inc.

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 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 ID15099590750961
NIH Device Record Key447148a5-f64d-45aa-99a2-84e64950dfa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess BNP Calibrators
Version Model Number98202
Catalog Number98202
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590750961 [Primary]

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-26
Device Publish Date2021-08-18

Devices Manufactured by Beckman Coulter, Inc.

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