FDA UDI
In Commercial Distribution
🇺🇸 United States
WELLlife™
DI: 00816862027006
·
Model: WCOVFLU-POC-5
·
WONDFO USA CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- WELLlife™
- Primary DI
- 00816862027006
- Version / Model
- WCOVFLU-POC-5
- Company Name
- WONDFO USA CO., LTD.
- Labeler DUNS
- 849098897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-05-16
- Public Version
- 1
- Public Version Date
- 2025-05-26
- Public Version Status
- New
- Public Device Record Key
- 5b9b5214-75dc-4cb3-b7c1-dccdc8416ca8
Device Description
WELLlife™ COVID-19 / Influenza A&B Antigen Test Cassette, 5 Tests per Kitbox
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
- No
- 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 |
|---|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | 866.3987 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64770 | Multiple-genus respiratory virus 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 multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses and/or adenoviruses. 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816862027003 | GS1 | 72 | In Commercial Distribution | ||
| Primary | 00816862027006 | GS1 | ||||
| Unit of Use | 00816862026993 | GS1 |
Customer Contacts
- Phone
- 630-468-2199
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius