Identity
- Trade Name
- SAS Serum/Urine hCG FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- SAS™ Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only. FDA UDI
- Model / Reference
- 087750 FDA UDI
- Description
- SAS™ Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000424 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 Serum/Urine hCG by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical.
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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 |
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Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI fc6a8873-6fa4-42b3-ae77-b1baa96cfd55 33 fields · synced May 30, 2026