Simplexa™ GBS Positive Control Pack MOL3560

GUDID 20816101025651

DIASORIN MOLECULAR LLC

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Primary Device ID20816101025651
NIH Device Record Key51fb5a4b-b06c-48fc-8a71-3110a2e9b7a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplexa™ GBS Positive Control Pack
Version Model NumberMOL3560
Catalog NumberMOL3560
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 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

Customer Support Contacts

Phone(800)838-4548
Emailtechnicalinfo.molecular@diasor
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasor
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.molecular@diasorin.com
Phone(800)838-4548
Emailtechnicalinfo.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
Phone562-240-6500
EmailTS.Molecular@DiaSorin.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120816101025651 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-21
Device Publish Date2018-11-20

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Trademark Results [Simplexa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLEXA
SIMPLEXA
79070362 3811076 Dead/Cancelled
Theben AG
2009-04-27
SIMPLEXA
SIMPLEXA
77444256 3818926 Live/Registered
DIASORIN MOLECULAR LLC
2008-04-09

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