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510(k) Data Aggregation
K Number
K062626Device Name
CORTISOL ELISA
Manufacturer
IBL-HAMBURG GMBH
Date Cleared
2006-12-20
(106 days)
Product Code
CGR
Regulation Number
862.1205Why did this record match?
Applicant Name (Manufacturer) :
IBL-HAMBURG GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IBL Cortisol enzym linked immunosorbent assay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.
The Cortisol ELISA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.
Device Description
Solid phase enzyme-linked immunosorbent assay (ELISA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
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K Number
K051144Device Name
ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
Manufacturer
IBL-HAMBURG GMBH
Date Cleared
2005-11-18
(198 days)
Product Code
NST
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IBL-HAMBURG GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitrodiagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma.
The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
Device Description
Not Found
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