Identity
- Trade Name
- GOODSENSE FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- One Step Pregnancy Test, 1 count FDA UDI
- Model / Reference
- G600944 FDA UDI
- Description
- One Step Pregnancy Test, 1 count FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846036009446 FDA UDI
- 510(k) Number
- K150022 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Goodsense by Geiss, Destin & Dunn, 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
- First Response Early Result Pregnancy Test — Church & Dwight Co., Inc. · Class II
- Easy@Home Pregnancy Test (8 HCG Midstreams) — EASY HEALTHCARE CORPORATION · Class II
- Oichid — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class II
- AMPLIM — AMPLIM, LLC · Class II
- Detector hCG — IMMUNOSTICS, INC. · Class II
- UCHECK — SCI Medic, Inc. · Class II
- Rite Aid — RITE AID CORPORATION · 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.
- Family Wellness — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP 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
- Geiss, Destin & Dunn, Inc
Sources (1)
- FDA UDI 59a5fea8-8e48-437d-8f1c-9ab448be9982 34 fields · synced Jun 1, 2026