Search Results
Found 1 results
510(k) Data Aggregation
K Number
K052525Device Name
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
Manufacturer
Date Cleared
2006-03-29
(196 days)
Regulation Number
862.1340Why did this record match?
Applicant Name (Manufacturer) :
D.F.I. CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reagent Strips for Urinalysis (qualitative and semi-quantitative) of Urobilinogen, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Nitrite, Leukocytes, and Ascorbic Acid in human urine.
CYBOW 11 Reagent Strips are for single use in professional near-patient (pointof-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:
- · Kidney function
- · Urinary tract infections
- · Carbohydrate metabolism (e.g. diabetes mellitus)
- · Liver function
- · Acid-base balance
- · Urine concentration
The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1