Sprinter XL

GUDID 04049016101499

EUROIMMUN Medizinische Labordiagnostika AG

Fluorescent immunoassay analyser IVD, laboratory
Primary Device ID04049016101499
NIH Device Record Key844e39a5-02fe-442b-ae07-b2fcc8fa8085
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprinter XL
Version Model NumberYG 0033-0101
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016101499 [Primary]

FDA Product Code

JQWStation, Pipetting And Diluting, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

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04049016151234 - FITC-labelled anti-human IgG 2024-11-18
04049016151562 - ELISA enzyme conjugate, anti-human IgA2024-11-18
04049016151593 - FITC-labelled anti-human IgA2024-11-18
04049016151609 - FITC-labelled anti-human IgG2024-11-18
04049016137894 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2024-09-19
04049016151999 - Mounting medium (IFA)2024-07-25

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