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510(k) Data Aggregation
K Number
K993480Device Name
K-ASSAY HAPTOGLOBIN
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-11-24
(41 days)
Product Code
DAD
Regulation Number
866.5460Why did this record match?
Product Code :
DAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K-ASSAY Haptoglobin Assay is intended to be used for the quantitative determination of Haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) relating to the formation of hemoglobin complexes and certain kidney diseases. FOR IN VITRO DIAGNOSTIC USE.
Device Description
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K Number
K972639Device Name
TINA-QUANT HAPTOGLOBIN
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1998-01-09
(178 days)
Product Code
DAD
Regulation Number
866.5460Why did this record match?
Product Code :
DAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoturbidometric assay for the quantitative in-vitro determination of Haptoglobin.
Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma.
Mcasurement of haptoglobin may aid in the diagnosis of hemolytic discases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglohin complexes and ccrtain kidncy discascs.
Device Description
The Haptoglobin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Haptoglobin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Haptoglobin antibodies (R₂ reagent) is added to mixture of the first step. The antibody will bind to the Haptoglobin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of Haptoglobin present in the sample.
The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Haptoglobin in the sample is directly proportional to the amount of turbidity formed.
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K Number
K964301Device Name
N-ASSAY TIA MULTI V-NL
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-07-14
(258 days)
Product Code
DAD
Regulation Number
866.5460Why did this record match?
Product Code :
DAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N-Assay TIA Haptoglobin Test Kit is intended to be used for the quantitation of haptoglobin in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.
Device Description
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K Number
K963286Device Name
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
Manufacturer
BECKMAN INSTRUMENTS, INC.
Date Cleared
1996-10-07
(47 days)
Product Code
DAD
Regulation Number
866.5460Why did this record match?
Product Code :
DAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
Device Description
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples.
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