AccessGUDID - DEVICE: QuickFinder™ COVID-19/Flu Antigen Self Test (08809115904423)

GUDID

Device Identifier (DI) Information

Brand Name: QuickFinder™ COVID-19/Flu Antigen Self Test
Version or Model: OI-01SU-CC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RAUCC02ENA1
Company Name: OSANG HEALTHCARE Co., Ltd.

Primary DI Number: 08809115904423
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688195374 *Terms of Use

Device Description: 2 Test / Kit

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):	No
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?
66464	SARS-CoV-2 antigen IVD, kit, rapid microfluidic immunoassay, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid microfluidic immunoassay method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to aid the diagnosis of coronavirus disease (COVID-19) infection. It is not intended to be used for self-testing.	Active	false
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
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
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25dbbdee-fd2c-42e6-b444-c42c7ccef9bd
Public Version Date: May 20, 2024
Public Version Number: 1
DI Record Publish Date: May 10, 2024