Identity
- Trade Name
- Family Wellness FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid FDA UDI
- Device Name
- Early Result Pregnancy Test 1CT FDA UDI
- Model / Reference
- 0939504 FDA UDI
- Description
- Early Result Pregnancy Test 1CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00032251057663 FDA UDI
- 510(k) Number
- K150022 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Family Wellness by Fourstar Group Inc. — 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
- OSOM hCG Card 5 Test kit — Sekisui Diagnostics, LLC · Class II
- Clinical Guard — Clinical Guard · Class II
- HCG COMBO, MERIDIAN 25 test Kit — Sekisui Diagnostics, LLC · Class II
Cleared under the same submission
K150022 also covers:
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Family Wellness — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP INC.
- GOODSENSE — GEISS, DESTIN & DUNN, INC
- GOODSENSE — GEISS, DESTIN & DUNN, INC
- Stix — Get Stix Inc.
- Modern Fertility Pregnancy Test — MODERN HEALTH
- Modern Fertility Pregnancy Test — MODERN HEALTH
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
- Fourstar Group Inc.
Sources (1)
- FDA UDI 95d93a9b-87da-4c41-b37f-8b1aa2a9d9b7 34 fields · synced May 30, 2026