EarliPoint

GUDID 00860009993709

Neurodevelopmental disorder interpretive software

Primary Device ID	00860009993709
NIH Device Record Key	473c75fd-0e52-4c1e-b98f-499708e06231
Commercial Distribution Status	In Commercial Distribution
Brand Name	EarliPoint
Version Model Number	EPT001
Company DUNS	117950776
Company Name	Earlitec Diagnostics, Inc.
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	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860009993709 [Primary]

QPF	Pediatric Autism Spectrum Disorder Diagnosis Aid

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
EARLIPOINT 90981008 not registered Live/Pending	EARLITEC DIAGNOSTICS, INC. 2021-04-29
EARLIPOINT 90680968 not registered Live/Pending	EARLITEC DIAGNOSTICS, INC. 2021-04-29
EARLIPOINT 87420431 not registered Live/Pending	Children's Healthcare of Atlanta, Inc. 2017-04-21