AccessGUDID - DEVICE: Flowflex COVID-19 Antigen Home Test (00682607660261)

GUDID

Device Identifier (DI) Information

Brand Name: Flowflex COVID-19 Antigen Home Test
Version or Model: L031-118B5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 660261
Company Name: Acon Laboratories, Inc.

Primary DI Number: 00682607660261
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 781100966 *Terms of Use

Device Description: Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1)

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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a494011-27c7-444b-85a1-a0148ec5c8e5
Public Version Date: June 20, 2025
Public Version Number: 3
DI Record Publish Date: November 01, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10682607660268	12	00682607660261	In Commercial Distribution	Case
20682607533262	300	20682607660265	In Commercial Distribution	Carton
20682607660265	288	10682607660268	In Commercial Distribution	Carton