Anti-nRNP/Sm ELISA (IgG)

GUDID 04049016027010

EUROIMMUN Medizinische Labordiagnostika AG

Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016027010
NIH Device Record Key6a58857e-e61b-404a-a5d7-dc74b0974a15
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-nRNP/Sm ELISA (IgG)
Version Model NumberEA 1591-9601 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016027010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKOAnti-Rnp Antibody, Antigen And Control

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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