ENA-6-Profile ELISA EIA-2780

GUDID 00840239027801

The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile in the diagnosis and treatment of autoimmune connective tissue disorders

DRG International Inc

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239027801
NIH Device Record Key147920b2-4693-460f-8819-617017208f34
Commercial Distribution StatusIn Commercial Distribution
Brand NameENA-6-Profile ELISA
Version Model NumberEIA-2780
Catalog NumberEIA-2780
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
GS100840239027801 [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

On-Brand Devices [ENA-6-Profile ELISA]

00840239027801The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of
00840239039019The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class ant
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