FDA.reportPublic FDA data

WELLlife™

Primary DI
10816862027409
Brand
WELLlife™
Company
WONDFO USA CO., LTD.
Model
WL03P0001-2S
Device description
WELLlife™ COVID-19 Antigen Home Test
Published
2025-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241317000Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co., Ltd.2024-09-30QYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816862027409PackageGS1144In Commercial Distribution
00816862027402PrimaryGS10
00816862027396Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202740910816862027409
00816862027402008168620274028168620274020816862027402
00816862027396008168620273968168620273960816862027396

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-468-2199wondfo@wondfousa.com

Regulatory Flags#

DUNS number
849098897
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816862027303WELLlife™WCOV-CON-52026-06-01
00816862028416WELLlife™WCOVID-POC-252026-06-01
00816862028294SAFElife™CDOA-L11135A32026-05-15
00816862028324WELLlife™ WFOB-OTC-2BX2026-05-15
00816862028348SAFElife™CDOA-6135F2026-05-15
00816862028362SAFElife™TDOA-6135F2026-05-15
00816862028393SAFElife™WEDDP-1142026-05-15
00816862028249SAFElife™CDOA-12135NT2026-01-15
00816862028270HORMONElife™H1-S-20BG2026-01-15
00816862027723HORMONElife™H1-S-E10-25BX-CLIA2026-01-15
00816862028164SAFElife™CDOA-12135NT2026-01-15
00816862028263HORMONElife™H1-S-20BG2026-01-15
00816862028027SAFElife™CDOA-L111452025-12-15
00816862028089SAFElife™CDOA-L11135A32025-12-15
00816862028102HORMONElife™H2-S-50BG2025-12-15
00816862028157HORMONElife™H1-C-25BX-CLIA2025-12-15
00816862028010SAFElife™CDOA-L111452025-12-15
00816862028072SAFElife™CDOA-L11135A32025-12-15
00816862028096HORMONElife™H2-S-50BG2025-12-15
00816862028119HORMONElife™H1-C-25BX-CLIA2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.QYT2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCQYT2026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00050428101735CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2025-08-08
00816862027402WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
00194346415908equateWAL-MART STORES, INC.QYT2025-05-22
10194346415905equateWAL-MART STORES, INC.QYT2025-05-22
00816862027280WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
10816862027287WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
06930251802365equateWAL-MART STORES, INC.QYT2025-04-05
16930251802362equateWAL-MART STORES, INC.QYT2025-04-05
00816862026252WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026276WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026290WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026259WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026273WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026297WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026238WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
00816862026177WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
10816862026235WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
30014613340188CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2024-11-20
00850042559666CorDx TyfastCORETESTS, INC.QYT2024-09-05
00850042559925CorDx TyfastCORETESTS, INC.QYT2024-09-05
00850042559932CorDx TyfastCORETESTS, INC.QYT2024-09-05