Entamoeba histolytica Ag (stool) ELISA EIA-3473

GUDID 00840239034731

This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces

DRG International Inc

Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239034731
NIH Device Record Key935c34d0-1f1f-4f5c-84f2-d1790bcb984e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEntamoeba histolytica Ag (stool) ELISA
Version Model NumberEIA-3473
Catalog NumberEIA-3473
Company DUNS075150847
Company NameDRG International Inc
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840239034731 [Primary]

FDA Product Code

GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-01
Device Publish Date2023-08-24

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