Identity
- Trade Name
- iHealth FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Model / Reference
- ICO-3000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850044118045 FDA UDI
- FDA Product Code
- GKP FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5400 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 II — 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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- 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
- 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ihealth Lab Inc.
Sources (1)
- FDA UDI 09bc2b5d-6ec9-444c-ab2f-e46791eb79f4 32 fields · synced May 30, 2026