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Found 4 results
510(k) Data Aggregation
K Number
K011400Device Name
MRSA-SCREEN
Manufacturer
DENKA SEIKEN'S
Date Cleared
2002-03-27
(324 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
DENKA SEIKEN'S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K013359Device Name
LP(A)-LATEX SEIKEN ASSAY KIT
Manufacturer
DENKA SEIKEN'S
Date Cleared
2002-03-08
(149 days)
Product Code
DFC
Regulation Number
866.5600Why did this record match?
Applicant Name (Manufacturer) :
DENKA SEIKEN'S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
Device Description
The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.
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K Number
K011958Device Name
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
Manufacturer
DENKA SEIKEN'S
Date Cleared
2001-12-04
(165 days)
Product Code
DCN
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
DENKA SEIKEN'S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRP-Latex (II) SEIKEN High Sensitivity Assay kit is a quantitative assay for use with an Automated Chemical Analyzer for the determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury, and inflammatory disorders.
Device Description
The CRP-Latex (II) SEIKEN High Sensitivity Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum. Antigen in the sample bonds to the specific anti-CRP antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on an automated analyzer (the Hitachi 717 was used for these studies), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
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K Number
K981734Device Name
VTEC-RPLA SEIKEN
Manufacturer
DENKA SEIKEN'S
Date Cleared
1998-09-22
(127 days)
Product Code
GNA
Regulation Number
866.3255Why did this record match?
Applicant Name (Manufacturer) :
DENKA SEIKEN'S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VTEC-RPLA "SEIKEN" is an in vitro diagnostic device for the detection and identification of verotoxic device for in culture isolates of E. coli and is intended as an aid in the diagnosis of Enterohemorrhagic E. coli (EHEC) infections.
Device Description
VTEC-RPLA "SEIKEN" is a reagent system which can be used for the detection of verotoxins in culture isolates of E. coli to aid in the diagnosis of EHEC infections. It employs antibody-antigen reactions as part of the assay and is based on reversed passive latex agglutination (RPLA). VTEC-RPLA utilizes polyclonal antibodies specific for each verotoxin type, VT1 and VT2, and thus may be used to identify toxins.
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