ANTI-PR3 (cANCA) ORG518

GUDID 04260157080171

Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. Thi

ORGENTEC Diagnostika GmbH

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
Primary Device ID04260157080171
NIH Device Record Key08c42179-4a5e-4f5c-a757-be8f54a066fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI-PR3 (cANCA)
Version Model NumberORG518
Catalog NumberORG518
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260157080171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

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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