Search Results
Found 3 results
510(k) Data Aggregation
K Number
K050576Device Name
MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
Manufacturer
GOOD BIOTECH CORP.
Date Cleared
2005-04-21
(45 days)
Product Code
DDZ, JIT, JJX
Regulation Number
866.5040Why did this record match?
Product Code :
DDZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease.
GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples.
GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis.
For In Vitro Diagnostic Use.
Device Description
Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations.
Ask a Question
K Number
K023860Device Name
MICROALBUMIN REAGENT SET AND CALIBRATORS
Manufacturer
POINTE SCIENTIFIC, INC.
Date Cleared
2003-04-28
(159 days)
Product Code
DDZ
Regulation Number
866.5040Why did this record match?
Product Code :
DDZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.
Device Description
Not Found
Ask a Question
K Number
K002674Device Name
RANDOX MICROALBUMIN
Manufacturer
RANDOX LABORATORIES, LTD.
Date Cleared
2000-10-05
(38 days)
Product Code
DDZ
Regulation Number
866.5040Why did this record match?
Product Code :
DDZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1