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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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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Trademark Results [VIDAS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIDAS
VIDAS
90812125 not registered Live/Pending
Compound Eye Inc.
2021-07-06
VIDAS
VIDAS
86649688 4935355 Live/Registered
bioMérieux
2015-06-03
VIDAS
VIDAS
79368562 not registered Live/Pending
ANGEL GEORGIEV LESOV
2023-03-09
VIDAS
VIDAS
79368562 not registered Live/Pending
SVETLA ATANASOVA LESOVA
2023-03-09
VIDAS
VIDAS
79171274 4916176 Live/Registered
bioMérieux
2015-05-28
VIDAS
VIDAS
77640911 3849276 Live/Registered
bioMérieux
2008-12-29
VIDAS
VIDAS
74072619 1785252 Live/Registered
VITEK SYSTEMS, INC.
1990-06-25

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