AccessGUDID - DEVICE: WELLlife™ (00816862026153)

GUDID

Device Identifier (DI) Information

Brand Name: WELLlife™
Version or Model: WV01P0001-2S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WONDFO USA CO., LTD.

Primary DI Number: 00816862026153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 849098897 *Terms of Use

Device Description: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox with Holder; SD

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:	No
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?
65454	SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing	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 intended to be used for self-testing by a layperson in the home or similar environment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMN	Covid-19 Multi-Analyte Antigen Device

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d8ea747-23ba-4e5b-b955-0c970471b01e
Public Version Date: January 01, 2025
Public Version Number: 1
DI Record Publish Date: December 24, 2024