Simplexa™ Influenza A H1N1 (2009)

GUDID 20816101025521

DIASORIN MOLECULAR LLC

Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT) Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID20816101025521
NIH Device Record Key7f8517fa-99a5-43a1-aa60-4c9f5e4e15b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplexa™ Influenza A H1N1 (2009)
Version Model NumberMOL2500
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.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

Device Identifiers

Device Issuing AgencyDevice ID
GS120816101025521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

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 Date2016-09-22

Devices Manufactured by DIASORIN MOLECULAR LLC

20816101027143 - Simplexa COVID-19 & Flu A/B Direct2023-07-03
20816101025835 - Simplexa Congenital CMV Direct2023-06-26
20816101025842 - Simplexa Congenital CMV Positive Control Pack2023-06-26
20816101027020 - Simplexa COVID-19 Direct2023-06-26
20816101027037 - Simplexa COVID-19 Positive Control Pack2023-06-26
20816101027150 - Simplexa COVID-19 & Flu A/B Positive Control Pack 2023-06-26
10816101022295 - DxSelect™ - Substrate Reagent2023-06-02
10816101025111 - Universal Disc Cover Tape2021-12-08

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.