Identity
- Trade Name
- SAS Sickle Cell Test FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, reagent FDA UDI
- Device Name
- The SAS™ Sickle Cell Test is intended to be used as an aid in the qualitative detection of hemoglobin S (Hb-S) in anticoagulated whole blood. The test does not distinguish between sickle cell disease (HbSS) and sickle cell trait (HbSA). This test is not recommended for use on newborns under 3 months of age. This test is for professional use. FDA UDI
- Model / Reference
- 094100 FDA UDI
- Description
- The SAS™ Sickle Cell Test is intended to be used as an aid in the qualitative detection of hemoglobin S (Hb-S) in anticoagulated whole blood. The test does not distinguish between sickle cell disease (HbSS) and sickle cell trait (HbSA). This test is not recommended for use on newborns under 3 months of age. This test is for professional use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000431 FDA UDI
- GMDN Term
- Haemoglobin S (HbS) IVD, reagent 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: Haemoglobin S (HbS) IVD, reagent
SAS Sickle Cell Test by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ASI Sickle Cell Test — Arlington Scientific, Inc. · Class II
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · 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 |
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Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI 245f4058-2224-4895-b34a-84f971f03fbf 33 fields · synced May 30, 2026