ANTI-SS-B ORG509

GUDID 04260157080065

ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODU

ORGENTEC Diagnostika GmbH

SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04260157080065
NIH Device Record Key2ea70e95-ee85-4d40-b0b8-3a993f3aab1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI-SS-B
Version Model NumberORG509
Catalog NumberORG509
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 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

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
GS104260157080065 [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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04260157080065 - ANTI-SS-B2018-07-06ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODU
04260157080065 - ANTI-SS-B2018-07-06 ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM
04260157080072 - ANTI-SM2018-07-06 ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA
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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