FDA.reportPublic FDA data

WELLlife™

Primary DI
10816862024705
Brand
WELLlife™
Company
WONDFO USA CO., LTD.
Model
WV01P0001-10
Device description
WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 10 Tests per Kitbox
Published
2024-12-20
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
QMNCovid-19 Multi-Analyte Antigen Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMNCovid-19 Multi-Analyte Antigen DeviceUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816862024705PackageGS154In Commercial Distribution
00816862024708PrimaryGS10
00816862024692Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202470510816862024705
00816862024708008168620247088168620247080816862024708
00816862024692008168620246928168620246920816862024692

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
10
DM exempt
false
Premarket exempt
true
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
00850044118656iHealthiHealth Labs Inc.QMN2026-05-15
00816862026863WELLlife™ WONDFO USA CO., LTD.QMN2025-05-16
10816862026860WELLlife™ WONDFO USA CO., LTD.QMN2025-05-16
00816862026153WELLlife™WONDFO USA CO., LTD.QMN2024-12-24
10816862026150WELLlife™WONDFO USA CO., LTD.QMN2024-12-24
00816862024586WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024630WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024661WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024685WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024708WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024722WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024583WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024637WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024668WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024682WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
10816862024729WELLlife™ WONDFO USA CO., LTD.QMN2024-12-20
00816862024500WELLlife™ WONDFO USA CO., LTD.QMN2024-09-24
10816862024507WELLlife™ WONDFO USA CO., LTD.QMN2024-09-24
30810107290041Flowflex Plus COVID-19 and Flu A/B Home TestACON LABORATORIES, INC.QMN2024-08-14
00850042559536CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559550CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559567CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850042559529CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559533CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559557CorDx TyfastCORETESTS, INC.QMN2024-06-13
10850042559564CorDx TyfastCORETESTS, INC.QMN2024-06-13
00850044118427iHealthiHealth Labs Inc.QMN2024-05-25
00850044118434iHealthiHealth Labs Inc.QMN2024-05-24
00850044118458iHealthiHealth Labs Inc.QMN2024-05-24
00850042559659CorDx TyfastCORETESTS, INC.QMN2024-04-11