Direct Amplification Disc

GUDID 30816101025085

DIASORIN MOLECULAR LLC

Microplate IVD
Primary Device ID30816101025085
NIH Device Record Key7e6ece51-be68-4310-b4fe-7cead3bc0cd0
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
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS130816101025085 [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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