AccessGUDID - DEVICE: OraSure Quick Flu 22-Count Flu A + B Kit (20608337000065)

GUDID

Device Identifier (DI) Information

Brand Name: OraSure Quick Flu 22-Count Flu A + B Kit
Version or Model: 1001-0320
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orasure Technologies, Inc.

Primary DI Number: 20608337000065
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:	No
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?
49119	Influenza A/B virus antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	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: e8d74a7f-4c77-4ecc-bf4b-910e05d25789
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: November 10, 2016