Anti-SS-A ELISA (IgG)

GUDID 04049016027034

EUROIMMUN Medizinische Labordiagnostika AG

SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016027034
NIH Device Record Key1ad20039-2c4e-491a-aa9b-cae1873ceb92
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-SS-A ELISA (IgG)
Version Model NumberEA 1595-9601 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
GS104049016027034 [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

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

04049016144595 - IFA: Oesophagus (Monkey) IgA EUROPattern2024-05-27
04049016125228 - EUROArrayScanner2023-11-28
04049016159704 - EUROPLUS Granulocyte Mosaic 322023-10-13
04049016159018 - UNIQO 1602023-09-28
04049016152989 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2023-07-13
04049016069355 - Adjustment solution2023-06-02
04049016151821 - Adjustment solution2023-06-02
04049016137740 - Free Testosterone ELISA2023-05-03

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