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Speedy Swab Rapid COVID-19 & FLU A+B Self-Test
FDA UDIClass N (US FDA UDI)
by WatMIND USA
Identity
- Trade Name
- Speedy Swab Rapid COVID-19 & FLU A+B Self-Test FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- CARTON-RDB-4V-4VUS4C30-SAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50810172700074 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Speedy Swab Rapid COVID-19 & FLU A+B Self-Test by WatMIND USA — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical.
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- GenBody COVID-19 Ag — Genbody Inc. · N
- Flowflex COVID-19 Antigen Home Test — ACON Laboratories, Inc. · N
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- WatMIND USA
Sources (1)
- FDA UDI 47ca86da-b00a-4d10-8ace-771bda470054 33 fields · synced Jun 8, 2026