Anti-Reticulin IgA Antibody(L) Test 5796AL

GUDID 00813545022990

SCIMEDX CORPORATION

Multiple Coeliac disease-associated antibody IVD, control
Primary Device ID00813545022990
NIH Device Record Key040af5b0-8258-467d-971b-d148918994b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Reticulin IgA Antibody(L) Test
Version Model Number5796AL
Catalog Number5796AL
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 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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813545022990 [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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

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