AccessGUDID - DEVICE: OraSure QuickFlu Positive and Negative Control Kit (00608337000054)

GUDID

Device Identifier (DI) Information

Brand Name: OraSure QuickFlu Positive and Negative Control Kit
Version or Model: 1001-0323
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orasure Technologies, Inc.

Primary DI Number: 00608337000054
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?
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
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
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 29774627-343e-4b31-8978-34627c79bb01
Public Version Date: January 22, 2021
Public Version Number: 2
DI Record Publish Date: March 23, 2018