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510(k) Data Aggregation
K Number
K981794Device Name
HICHEM CALCIUM REAGENT KIT
Manufacturer
HICHEM DIAGNOSTICS
Date Cleared
1998-07-29
(69 days)
Product Code
CJY
Regulation Number
862.1145Why did this record match?
Applicant Name (Manufacturer) :
HICHEM DIAGNOSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Device Description
The HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.
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K Number
K963383Device Name
HICHEM ALP/AMP REAGENT KIT
Manufacturer
HICHEM DIAGNOSTICS
Date Cleared
1996-09-23
(27 days)
Product Code
CKF
Regulation Number
862.1050Why did this record match?
Applicant Name (Manufacturer) :
HICHEM DIAGNOSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.
Device Description
The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
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