Anti-SS-B ELISA (IgG)

GUDID 04049016027041

EUROIMMUN Medizinische Labordiagnostika AG

SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016027041
NIH Device Record Key39640c28-e57f-495c-8304-9a5eba44489a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-SS-B ELISA (IgG)
Version Model NumberEA 1597-9601 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
GS104049016027041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLLExtractable Antinuclear 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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