Anti-PLA2R ELISA (IgG)

GUDID 04049016102748

EUROIMMUN Medizinische Labordiagnostika AG

Phospholipase A2 receptor (PLA2R) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016102748
NIH Device Record Key5c75a674-9900-4ddc-9fc4-f484b9f4b24c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-PLA2R ELISA (IgG)
Version Model NumberEA 1254-9601 G
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016102748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGVAnti-Phospholipase A2 Receptor

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 Date2016-09-24

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