Schistosoma Antibody 96 Tests SCHISTO-96

GUDID 00813545026455

SCIMEDX CORPORATION

Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00813545026455
NIH Device Record Key2918d733-9f39-4449-9859-7dfd17e92dff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSchistosoma Antibody 96 Tests
Version Model NumberSCHISTO-96
Catalog NumberSCHISTO-96
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
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813545026455 [Primary]

FDA Product Code

GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni

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 Date2016-09-21

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00813545026561 - MeDiCa2020-12-09 Rat Liver 4 Well Slide (each)
00813545026578 - MeDiCa2020-12-09 Rat Liver 8 Well Slide (each)
00813545026585 - MeDiCa2020-12-09 Crithidia luciliae 4 Well Slide (each)
00813545026592 - MeDiCa2020-12-09 Crithidia luciliae 8 Well Slide (each)

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