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510(k) Data Aggregation
K Number
K972382Device Name
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
Manufacturer
Date Cleared
1998-09-14
(445 days)
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
ARROWS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UB analyzer UA-2 and its exclusive reagent kit are designed to determine both total and unbound bilirubin concentration in neonatal serum using exclusive reagent kit, "UB TEST." The total bilirubin and unbound bilirubin concentration in neonatal serum can be used to provide the physician with additional information in the clinical assessment of jaundiced neonates and the possible risk of bilirubin encephalopathy.
Device Description
The UB analyzer UA-2 is designed to determine both the total and unbound bilirubin concentrations in neonatal serum quantitatively with rapidity and accuracy. Determined concentrations of total bilirubin and unbound bilirubin are digitally displayed on LCD and printed out with UB/TB ratio and determined date. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
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