Identity
- Trade Name
- iHealth FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Model / Reference
- ICF-3000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850044118434 FDA UDI
- FDA Product Code
- QPK 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
iHealth by Ihealth Lab Inc. — 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, self-testing.
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- BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc. · N
- WELLlife™ — WONDFO USA CO., LTD. · N
- Boson - Rapid SARS-CoV-2 Antigen Test Card - 5 Tests/Kit — Xiamen Boson Biotech Co., Ltd. · 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
- Ihealth Lab Inc.
Sources (1)
- FDA UDI 9da162e3-b48a-440d-b403-f9b0cc3fd0a8 32 fields · synced Jun 8, 2026