ICA(MP) 48 Test(L) 5548L

GUDID 00813545022907

SCIMEDX CORPORATION

Islet cell antibody IVD, kit, fluorescent immunoassay
Primary Device ID00813545022907
NIH Device Record Key336bba9d-e866-4ca0-bf6f-1111cbc78e59
Commercial Distribution StatusIn Commercial Distribution
Brand NameICA(MP) 48 Test(L)
Version Model Number5548L
Catalog Number5548L
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
GS100813545022907 [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 Date2016-09-19

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