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Rapid Response Midstream Pregnancy Test
FDA UDIClass II (US FDA UDI)
by BTNX Inc
Identity
- Trade Name
- Rapid Response Midstream Pregnancy Test FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The Rapid Response hCG Pregnancy Midstream Test is a rapid, self-performing, qualitative test for the determination of human chorionic gonadotropin in human urine specimens, to aid in the early detection of pregnancy. FDA UDI
- Model / Reference
- HCG-1M1 FDA UDI
- Description
- The Rapid Response hCG Pregnancy Midstream Test is a rapid, self-performing, qualitative test for the determination of human chorionic gonadotropin in human urine specimens, to aid in the early detection of pregnancy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00722066005323 FDA UDI
- 510(k) Number
- K122907 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
Rapid Response Midstream Pregnancy Test by BTNX 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
K122907 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 |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 97e7155a-87ac-485e-8b55-6f062005c5ac 34 fields · synced May 30, 2026