AccessGUDID - DEVICE: OraSure Quickflu Nasopharyngeal Wash / Aspirate (00608337000047)

GUDID

Device Identifier (DI) Information

Brand Name: OraSure Quickflu Nasopharyngeal Wash / Aspirate
Version or Model: 1001-0321
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orasure Technologies, Inc.

Primary DI Number: 00608337000047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 114152184 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083746	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 30d9a8d8-d626-4dcc-ab7c-10fe065ceed4
Public Version Date: January 22, 2021
Public Version Number: 4
DI Record Publish Date: November 25, 2016