Universal Disc

GUDID 30816101025078

DIASORIN MOLECULAR LLC

Microplate IVD Microplate IVD
Primary Device ID30816101025078
NIH Device Record Keyf1244383-7e6e-40d5-a888-2997ca918feb
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Disc
Version Model NumberMOL1401
Company DUNS080271715
Company NameDIASORIN MOLECULAR LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130816101025078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

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

On-Brand Devices [Universal Disc]

40816101025075MOL1400
30816101025078MOL1401

Trademark Results [Universal Disc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIVERSAL DISC
UNIVERSAL DISC
77376425 not registered Dead/Abandoned
John B. Geier & Associates, Inc.
2008-01-21

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