P KDY Pack 4 WELL 5601

GUDID 00813545020583

SCIMEDX CORPORATION

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
Primary Device ID00813545020583
NIH Device Record Keyb70bea9e-94a4-460d-8af7-c55497d4649e
Commercial Distribution StatusIn Commercial Distribution
Brand NameP KDY Pack 4 WELL
Version Model Number5601
Catalog Number5601
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
GS100813545020583 [Primary]

FDA Product Code

MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

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 Date2016-09-16

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