Identity
- Trade Name
- INVBIO FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It consists of 25 strips. FDA UDI
- Model / Reference
- 81316 FDA UDI
- Description
- HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It consists of 25 strips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938444981316 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Invbio by Equinox Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Equinox Biotech Co., Ltd.
Sources (1)
- FDA UDI 2234c1f6-ce10-413a-828f-8ce399602726 35 fields · synced May 30, 2026