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SAS Sickle Cell Test

SA SCIENTIFIC, LTD. · Model 094100 · UDI-DI 00780311000431

Prescription
0
510(k) clearances
0
Adverse events
0
Recalls
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Facilities

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.