OraSure QuickFlu Positive and Negative Control Kit

Basic Information

• Brand Name: OraSure QuickFlu Positive and Negative Control Kit
• Primary DI: 00608337000054
• Version / Model: 1001-0323
• Company Name: Orasure Technologies, Inc.
• Labeler DUNS: 114152184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-23
• Public Version: 2
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 29774627-343e-4b31-8978-34627c79bb01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
57954	Nasopharyngeal aspirate container IVD	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a nasopharyngeal aspirate specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Obsolete
49122	Influenza A/B virus antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen.	No	Active
49121	Influenza A/B virus antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00608337000054	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius