Direct Amplification Disc

GUDID 40816101025082

DIASORIN MOLECULAR LLC

Microplate IVD Microplate IVD
Primary Device ID40816101025082
NIH Device Record Keyf4dd022a-190d-48d6-ac36-3ca8794d1a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect Amplification Disc
Version Model NumberMOL1451
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
GS140816101025082 [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 [Direct Amplification Disc ]

40816101025082MOL1451
30816101025085MOL1451

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