Anti-Jo-1 ELISA EIA-3581

GUDID 04048474035810

Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies against Jo-1 in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474035810
NIH Device Record Key36590c13-e6d5-4b10-a9fe-8d33dd0273dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Jo-1 ELISA
Version Model NumberEIA-3581
Catalog NumberEIA-3581
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104048474035810 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-30
Device Publish Date2019-06-10

On-Brand Devices [Anti-Jo-1 ELISA]

00404847435818Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies agains
04048474035810Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies agains

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