ENA Screen ELISA EIA-3571

GUDID 04048474035711

ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma .samples.

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474035711
NIH Device Record Key715dc62b-be56-4673-8dca-2ad9df1cc414
Commercial Distribution StatusIn Commercial Distribution
Brand NameENA Screen ELISA
Version Model NumberEIA-3571
Catalog NumberEIA-3571
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@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
GS104048474035711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLLEXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-30
Device Publish Date2019-06-10

On-Brand Devices [ENA Screen ELISA]

00404847435719ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies agai
04048474035711ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies agai

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