Simplexa™ C. auris Sample Prep Kit MOL5390

GUDID 20816101027235

DIASORIN MOLECULAR LLC

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID20816101027235
NIH Device Record Keyf9e3ff79-e6cc-4036-8f28-27c8089bf214
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplexa™ C. auris Sample Prep Kit
Version Model NumberMOL5390
Catalog NumberMOL5390
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS120816101027235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SBTDevice To Detect Microbial Colonization Directly From Clinical Specimens.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-29
Device Publish Date2024-07-19

Devices Manufactured by DIASORIN MOLECULAR LLC

10816101027207 - Factor V HyBeacon II Primer Pair2024-10-02
10816101027221 - Prothrombin (FII) HyBeacon Gen II Primer Pair2024-10-02
10816101027283 - Monkeypox Primer Pair2024-08-30
10816101027290 - Human GAPDH Endogenous Primer Pair2024-08-30
20816101027198 - Simplexa™ C. auris Direct2024-07-29
20816101027211 - Simplexa™ C. auris Positive Control Pack2024-07-29
20816101027235 - Simplexa™ C. auris Sample Prep Kit2024-07-29
20816101027235 - Simplexa™ C. auris Sample Prep Kit2024-07-29
10816101022240 - DxSelect™ Amber Sample Diluent2024-07-09

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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