P. ESG PACK 4 WELL 5301

GUDID 00813545020460

SCIMEDX CORPORATION

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Primary Device ID00813545020460
NIH Device Record Key84302d8d-8301-4cec-a33c-0313aa6cd1fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameP. ESG PACK 4 WELL
Version Model Number5301
Catalog Number5301
Company DUNS155424708
Company NameSCIMEDX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813545020460 [Primary]

FDA Product Code

DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-08
Device Publish Date2016-09-16

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