Express HIV-1 Test System

GUDID M769HIVEXPRESS201

Home blood collection kit

Primary Device ID	M769HIVEXPRESS201
NIH Device Record Key	74914157-a27c-4b4e-b8cd-f60b12da3d0a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Express HIV-1 Test System
Version Model Number	20
Company DUNS	848511283
Company Name	Home Access Health Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
HIBCC	M769HIVEXPRESS201 [Primary]

MVZ	System,Test,Home,Hiv-1

Steralize Prior To Use	false
Device Is Sterile	false

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