Hepatitis C Check

GUDID M769HCV271

The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HCV (Hepatitis C) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing.

Home Access Health Corporation

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Primary Device IDM769HCV271
NIH Device Record Key1334b700-2c3a-4a02-9ec7-ffa2c152ce44
Commercial Distribution StatusIn Commercial Distribution
Brand NameHepatitis C Check
Version Model Number27
Company DUNS848511283
Company NameHome Access Health Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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-Countertrue

Customer Support Contacts

Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM769HCV271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZOAssay,Enzyme Linked Immunosorbent,Hepatitis C Virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-07
Device Publish Date2015-09-03

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