Anti-Glutamate receptor (type NMDA) IFA

GUDID 04049016092551

EUROIMMUN Medizinische Labordiagnostika AG

N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay
Primary Device ID04049016092551
NIH Device Record Keyd1174a6a-d115-49bf-9dae-e9918eafa4ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Glutamate receptor (type NMDA) IFA
Version Model NumberFA 112d-1010-51
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
GS104049016092551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSKAnti-Glutamate Receptor (Type Nmda) Ifa

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-Glutamate receptor (type NMDA) IFA]

04049016092575FA 112d-2010-51
04049016092568FA 112d-2005-51
04049016092551FA 112d-1010-51
04049016092544FA 112d-1005-51
04049016092537FA 112d-1003-51

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