Identity
- Trade Name
- Healgen FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid FDA UDI
- Device Name
- hCG women pregnancy Test (Urine, 25mIU/ml) FDA UDI
- Model / Reference
- GAHCG-105a FDA UDI
- Description
- hCG women pregnancy Test (Urine, 25mIU/ml) FDA UDI
Identifiers
- Catalog Number
- GAHCG-105a FDA UDI
- Primary DI / UDI-DI
- 00816490021261 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
Yes
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
Healgen by Healgen Scientific Limited Liability Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid.
- Clinical Guard — Clinical Guard · Class II
- RAPID DIAGNOSTICS HCG TEST CARD — RAPID DIAGNOSTICS INC · Class II
- OSOM hCG Card 25 Test Kit — Sekisui Diagnostics, LLC · Class II
- QuickProfile™ HCG Test Strip — LumiQuick Diagnostics, Inc. · Class II
- EZ-hCG Urine Pregnancy Test — BIOMERICA, INC. · Class II
- Family Wellness — FOURSTAR GROUP INC. · Class II
- OSOM hCG Card 5 Test kit — Sekisui Diagnostics, LLC · Class II
- Clinical Guard — Clinical Guard · Class II
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
- Healgen Scientific Limited Liability Company
Sources (1)
- FDA UDI 69fb61e9-e1ef-4b91-8a52-5fceaf2bdabf 36 fields · synced Jun 8, 2026