Elecsys proBNP II STAT Immunoassay 09315276160

GUDID 07613336191576

proBNP G2 STAT Elecsys cobas e 100 V2.1

Roche Diagnostics GmbH

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336191576
NIH Device Record Key90e0afb8-4cfa-4763-9066-642e1967990e
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys proBNP II STAT Immunoassay
Version Model Number09315276160
Catalog Number09315276160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS107613336191576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBCTest, natriuretic peptide

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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07613336183236 - PreciControl HBsAg II Auto Confirm2024-11-15
07613336234402 - navify® Lab Operations2024-11-05
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