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510(k) Data Aggregation
K Number
K961375Device Name
DIA SCREEN 10 WAY REAGENT STRIPS
Manufacturer
GENESIS LABS, INC.
Date Cleared
1996-06-18
(70 days)
Product Code
JIL, CEN, JIO, JJB, JMT
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
GENESIS LABS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semiquantitative urinalysis. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to test semiguantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, billirubin, and urobilinogen by visual comparison with a color chart.
Device Description
DIA SCREEN® Reagent Strips are plastic strips to which are affixed reagent areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen,
The reagent test areas on the DIA SCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
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