25-OH Vitamin D ELISA

GUDID 04049016097129

EUROIMMUN Medizinische Labordiagnostika AG

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016097129
NIH Device Record Keye7a2b1a7-3160-43a3-b0fd-35daa270b86e
Commercial Distribution StatusIn Commercial Distribution
Brand Name25-OH Vitamin D ELISA
Version Model NumberEQ 6411-9601
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
GS104049016097129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRGSystem, Test, Vitamin D

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

04049016137894 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2024-09-19
04049016151999 - Mounting medium (IFA)2024-07-25
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

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