Anti-HBs CalCheck

GUDID 07613336159804

Anti-HBs CC 3 Elecsys

Roche Diagnostics GmbH

Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control Hepatitis B virus surface total antibody IVD, control
Primary Device ID07613336159804
NIH Device Record Keya2d90031-0496-410e-b96a-137bc7b5d687
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-HBs CalCheck
Version Model Number04985354160
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336159804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-30
Device Publish Date2018-08-30

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