Anti-PLA2R IFA

GUDID 04049016095781

EUROIMMUN Medizinische Labordiagnostika AG

Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016095781
NIH Device Record Key7e888142-6bca-45bc-9509-1b3e54b6fa82
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-PLA2R IFA
Version Model NumberFA 1254-1005-50
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016095781 [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 Date2016-10-10

On-Brand Devices [Anti-PLA2R IFA]

04049016095804FA 1254-2005-50
04049016095798FA 1254-1010-50
04049016095781FA 1254-1005-50
04049016095774FA 1254-1003-50
04049016138501FA 1254-2010-50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.