Identity
- Trade Name
- Detector hCG Personal FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Home pregnancy test for early results FDA UDI
- Model / Reference
- IDP-25 FDA UDI
- Description
- Home pregnancy test for early results FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355002887 FDA UDI
- 510(k) Number
- K960174 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
- 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
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Detector hCG Personal by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical.
- MGC HEALTH — Guangzhou Decheng Biotechnology Co., LTD · Class II
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- Oichid — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class II
- AMPLIM — AMPLIM, LLC · Class II
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- Care One — Ahold U.S.A., Inc. · Class II
Cleared under the same submission
K960174 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI 4bb29829-fb5a-4368-bd5d-3926361a2cef 36 fields · synced Jun 8, 2026