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INDICAID COVID-19 Rapid Antigen At-Home Test
FDA UDIEUDAMEDClass N (US FDA UDI)
Identity
- Trade Name
- INDICAID COVID-19 Rapid Antigen At-Home Test FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Model / Reference
- 2-Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897116730947 FDA UDI
- FDA Product Code
- QKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing 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
No
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, self-testing
INDICAID COVID-19 Rapid Antigen At-Home Test by Phase Scientific International Limited — Class N — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing.
- Status™ COVID-19 Antigen Rapid Test for Home Use — PRINCETON BIOMEDITECH CORP. · N
- QuickFinder COVID-19 Antigen Self Test — OSANG HEALTHCARE Co., Ltd.
- WELLlife™ — WONDFO USA CO., LTD. · N
- BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc. · N
- iHealth — IHEALTH LAB INC. · N
- Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit — Xiamen Boson Biotech Co., Ltd. · N
- BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc. · N
- WELLlife™ — WONDFO USA CO., LTD. · N
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class N | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Phase Scientific International Limited
Sources (2)
- FDA UDI 44ff945c-5d8a-4a5a-bee0-f8d0a6a1c1ac 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026