Identity
- Trade Name
- SAS One-Step Pregnancy FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- SAS™ One-Step Pregnancy is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only. FDA UDI
- Model / Reference
- 087430 FDA UDI
- Description
- SAS™ One-Step Pregnancy is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000196 FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
SAS One-Step Pregnancy by Sa Scientific, Ltd — 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
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI c5c7cd25-7ec8-444d-adfd-37ed9d038e7d 33 fields · synced Jun 1, 2026