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510(k) Data Aggregation
K Number
K091472Device Name
URITEST 50 AND URITEST 500 URINE ANALYZER
Manufacturer
ARJ MEDICAL, INC.
Date Cleared
2010-04-27
(344 days)
Product Code
KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, LJX
Regulation Number
862.2900Why did this record match?
Applicant Name (Manufacturer) :
ARJ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ARJ Medical URITEST 50 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARI Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.
ARI Medical URITEST 50 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration
ARJ Medical Uritest 500 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.
ARJ Medical URITEST 500 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration
Device Description
ARJ Medical Uritest 50 and Uritest 500 urine analyzer is a kind of semi-automatic photoelectronic colorimeter that can be used together with the Uritest 10 Urine Reagent Strips manufactured by ARJ Medical, Inc. Adopting the advanced "super-high luminosity cold light source reflection determination" technology, the "high luminosity cold light source" has two main advantages. (1) the usable life of a cold light is longer than the normal light source (2) the temperature of the normal light source will increase during testing, affecting the test result vs the temperature of the cold light source is constant not potentially affecting the result. It can finish the tests on 10 kinds of biochemical components in urine within 30 seconds, and it also can revise the affects toward the test result which is caused by ambient temperature, ambient light, acid-base scale and abnormally colored sample. The Uritest 50 and Uritest 500 urine analyzers are in vitro-diagnostic devices (IVDD).
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K Number
K052719Device Name
URITEST 10 URINALYSIS REAGENT STRIPS
Manufacturer
ARJ MEDICAL, INC.
Date Cleared
2006-12-05
(432 days)
Product Code
CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX
Regulation Number
862.1785Why did this record match?
Applicant Name (Manufacturer) :
ARJ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
URITEST 10 Urinalysis Reagent Strips provide qualitative and sem-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.
ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas:
Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration
Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
Device Description
URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones. blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.
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K Number
K052708Device Name
PYLO-PLUS
Manufacturer
ARJ MEDICAL, INC.
Date Cleared
2006-05-01
(214 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
ARJ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric I your id is intended for the presumptive determination of Helicobacter pylori in symptomatic patients. ARJ Medical's Pylo-Plus Rapid Urease Tests are for single use by medical and ANJ Medical 3 1 710 1 148 Rapia Created for use in screening at-risk patients to assist diagnosis in the field of Gastroenterology.
Device Description
Pylo-Plus is a Rapid Urease Test.
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