FDA UDI
In Commercial Distribution
🇺🇸 United States
WELLlife™
DI: 00816862026177
·
Model: WL03P0001-1
·
WONDFO USA CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- WELLlife™
- Primary DI
- 00816862026177
- Version / Model
- WL03P0001-1
- Company Name
- WONDFO USA CO., LTD.
- Labeler DUNS
- 849098897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 2
- Public Version Date
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- b925ddbe-659f-4ead-bf33-f7c0faca1fff
Device Description
WELLlife™ COVID-19 Antigen Home Test Cassette, 1 Test per Kitbox with Holder
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QYT | Over-The-Counter Covid-19 Antigen Test | Microbiology | 866.3984 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816862026177 | GS1 | ||||
| Package | 10816862026174 | GS1 | 216 | In Commercial Distribution |
Customer Contacts
- Phone
- 630-468-2199
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius