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Sweat Control Level 1, 2, & 3 Set 9x3mL

QUANTIMETRIX CORPORATION · Model 1190-01 · UDI-DI 00896863002028

JJR
1
510(k) clearances
2
Adverse events
0
Recalls
11
Facilities

Description

The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures and to validate the analysis of Chloride, Potassium, and Sodium by confirmatory methods used to quantitate patient samples. They are liquid, ready-to-use, requiring no reconstitution or dilution. They are supplied in three levels, nine vials per box, 3x3mL each level. They are prepared in an aqueous simulated human sweat matrix to which preservatives have been added.

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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.