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510(k) Data Aggregation
K Number
K081709Device Name
OLYMPUS AFP - ALPHA-FETOPROTEIN
Manufacturer
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
Date Cleared
2009-03-16
(272 days)
Product Code
LOJ, JIT, JJY
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors.
For in vitro diagnostic use only.
The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System.
The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.
Device Description
The Olympus Alpha-fetoprotein (AFP) Test System is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System.
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K Number
K080435Device Name
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
Manufacturer
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
Date Cleared
2008-09-05
(199 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers.
Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
For in vitro diagnostic use.
Device Description
The Olympus Direct Bilirubin Reagent (OSR6X181) is a system reagent.
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K Number
K080094Device Name
OLYMPUS TOTAL BHCG TEST SYSTEN
Manufacturer
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
Date Cleared
2008-09-03
(233 days)
Product Code
DHA, JIT, JJX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only.
The Olympus ßhCG Calibrator is for calibrating the quantitative Olympus ßhCG assay on the Olympus AU3000i Immunoassay System.
The Olympus BhCG Control is used for quality control of the Olympus BhCG assay on the Olympus AU3000i Immunoassay System.
Device Description
The Olympus Total BhCG Test System (OS210303). The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System.
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