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CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box
FDA UDIClass II (US FDA UDI)
by WatMIND USA
Identity
- Trade Name
- CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810172700069 FDA UDI
- FDA Product Code
- QYT FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3984 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box by WatMIND USA — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical.
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- Flowflex COVID-19 Antigen Home Test — ACON Laboratories, Inc. · N
- SCoV-2 Ag Detect™ Rapid Test — InBios International, Inc.
- SCoV-2 Ag Detect™ Rapid Test — InBios International, Inc.
- 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 II | Pending data |
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Manufacturer
- Manufacturer
- WatMIND USA
Sources (1)
- FDA UDI 3eb1e3d1-10f6-4408-b8ca-250460619666 32 fields · synced May 30, 2026