ENA Screen (entractable nuclear antigen) ELISA EIA-2779

GUDID 00840239027795

The DRG ENA Screen IgG ELISA Test System is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70.

DRG International Inc

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239027795
NIH Device Record Key43d74c2f-889f-4d8d-aa42-76076a064b9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameENA Screen (entractable nuclear antigen) ELISA
Version Model NumberEIA-2779
Catalog NumberEIA-2779
Company DUNS075150847
Company NameDRG International Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840239027795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-31
Device Publish Date2023-08-23

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