Simplexa™ Influenza A H1N1 (2009)

Basic Information

• Brand Name: Simplexa™ Influenza A H1N1 (2009)
• Primary DI: 20816101025521
• Version / Model: MOL2500
• Company Name: DIASORIN MOLECULAR LLC
• Labeler DUNS: 080271715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7f8517fa-99a5-43a1-aa60-4c9f5e4e15b8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OQW	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification	Microbiology	866.3332	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49165	Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus H1N1 subtype (swine influenza) in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20816101025521	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100148	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -10 Degrees Celsius