ANTI-RPN/SM ORG511

GUDID 04260157080089

ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM OR PLASMA. THIS PRODUC

ORGENTEC Diagnostika GmbH

U1-RNP antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04260157080089
NIH Device Record Keye45ae59f-3dc1-4d02-a072-7e1743b393f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI-RPN/SM
Version Model NumberORG511
Catalog NumberORG511
Company DUNS328133103
Company NameORGENTEC Diagnostika GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM
Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.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
GS104260157080089 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

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04260157080089 - ANTI-RPN/SM2018-07-06 ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM O
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