AccessGUDID - DEVICE: Flowflex COVID-19 Antigen Home Test (00682607660278)

GUDID

Device Identifier (DI) Information

Brand Name: Flowflex COVID-19 Antigen Home Test
Version or Model: L031-125M5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 660278
Company Name: ACON LABORATORIES, INC.

Primary DI Number: 00682607660278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 781100966 *Terms of Use

Device Description: Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)

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):	Yes
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?
64787	SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), 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
QKP	Coronavirus antigen detection test system.

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
Special Storage Condition, Specify: The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
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: 5b1b1baf-0312-4f50-93ae-63b8e89f9732
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: November 22, 2021