VIDAS® Prolactin

GUDID 03573026156961

VIDAS ® Prolactin (PRL) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of prolactin concentration in human serum or plasma .

BIOMERIEUX SA

Prolactin IVD, kit, enzyme immunoassay (EIA)
Primary Device ID03573026156961
NIH Device Record Key2cd58615-5896-409c-8909-b171ed932df6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDAS® Prolactin
Version Model Number30410-01
Company DUNS276816717
Company NameBIOMERIEUX SA
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026156961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFTRADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

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