Simplexa™ C. difficile Direct

GUDID 20816101025590

DIASORIN MOLECULAR LLC

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID20816101025590
NIH Device Record Key20c40d67-5034-49fd-9204-d1f677acf7d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplexa™ C. difficile Direct
Version Model NumberMOL2950
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

Operating and Storage Conditions

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
GS120816101025590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZNC.Difficile Toxin Gene Amplification Assay

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 Date2017-02-16

Devices Manufactured by DIASORIN MOLECULAR LLC

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20816101027150 - Simplexa COVID-19 & Flu A/B Positive Control Pack 2023-06-26
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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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