Identity
- Trade Name
- SAS hCG Serum Control Set FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, control FDA UDI
- Device Name
- SAS™ hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Serum/Urine hCG pregnancy test kits. These controls are for professional use only. FDA UDI
- Model / Reference
- 087712 FDA UDI
- Description
- SAS™ hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Serum/Urine hCG pregnancy test kits. These controls are for professional use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000103 FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, control 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, control
SAS hCG Serum Control Set 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, control.
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- AdexusDx hCG Control Set (unassayed) — NOWDIAGNOSTICS, INC. · Class I
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- Atellica™ IM ThCG MCM — Siemens Healthcare Diagnostics · Class II
- hCG Control Slides — BIO SB, INC. · Class I
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 d24e5b43-11bc-4516-8449-01274a31485a 33 fields · synced Jun 1, 2026