FDA UDI
In Commercial Distribution
🇺🇸 United States
SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box
DI: 00810172700000
·
Model: SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box
·
WatMIND USA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box
- Primary DI
- 00810172700000
- Version / Model
- SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box
- Company Name
- WatMIND USA
- Labeler DUNS
- 117617770
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-10
- Public Version
- 1
- Public Version Date
- 2024-07-18
- Public Version Status
- New
- Public Device Record Key
- 9619512b-17c0-4f8d-a2c8-22e5cb4ec6f1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 64787 | SARS-CoV-2 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 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 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 |
|---|---|---|---|---|---|---|
| Primary | 00810172700000 | GS1 |