Athelas Home

GUDID 00860008385840

Athelas, Inc.

Haematological cell analyser IVD, automated
Primary Device ID00860008385840
NIH Device Record Key48531e2b-3a98-4fae-8c1a-84850b9177d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAthelas Home
Version Model Number850-00001-00
Company DUNS080636378
Company NameAthelas, Inc.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008385840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-08
Device Publish Date2022-07-29

On-Brand Devices [Athelas Home]

00860008385864850-00002-00
00860008385840850-00001-00

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