RHEUMATOID FACTOR IgM ORG522M

GUDID 04260157080256

Rheumatoid Factor IgM is an ELISA test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma. This product

ORGENTEC Diagnostika GmbH

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
Primary Device ID04260157080256
NIH Device Record Keyc3ef6575-d895-4c34-810c-a61a51a401c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRHEUMATOID FACTOR IgM
Version Model NumberORG522M
Catalog NumberORG522M
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
GS104260157080256 [Primary]

FDA Product Code

DHRSystem, Test, Rheumatoid Factor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-31

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