Elecsys Anti-HAV II 08086630190

GUDID 07613336129722

Roche Diagnostics GmbH

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336129722
NIH Device Record Key5aea102d-2c80-41e4-8600-7e831e7e4e45
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Anti-HAV II
Version Model Number08086630190
Catalog Number08086630190
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 Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336129722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOLHepatitis a test (antibody and igm antibody)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-08
Device Publish Date2019-09-30

On-Brand Devices [Elecsys Anti-HAV II]

0761333612972208086630190
0761333612971508086664190

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