Elecsys proBNP II STAT CalSet 09315306190

GUDID 07613336191545

proBNP STAT CS Elecsys V2.1

Roche Diagnostics GmbH

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 ID07613336191545
NIH Device Record Key7e5fc3e6-154b-4c10-bc75-93302d97556c
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys proBNP II STAT CalSet
Version Model Number09315306190
Catalog Number09315306190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS107613336191545 [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 Date2022-05-16
Device Publish Date2022-05-07

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