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510(k) Data Aggregation
K Number
K040431Device Name
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2004-03-10
(20 days)
Product Code
DAO
Regulation Number
866.5550Why did this record match?
Product Code :
DAO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers.
Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Device Description
The Tina-quant IgM Gen.2 is an immunoturbidimetric assay. Anti-IgM antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
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K Number
K982639Device Name
SPIFE URINE IFE
Manufacturer
HELENA LABORATORIES
Date Cleared
1998-11-04
(98 days)
Product Code
DAO
Regulation Number
866.5550Why did this record match?
Product Code :
DAO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation. This kit could be a useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.
Device Description
Not Found
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K Number
K955908Device Name
BOEHRINGER MANNHEIM IGM ASSAY
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1996-02-09
(42 days)
Product Code
DAO
Regulation Number
866.5550Why did this record match?
Product Code :
DAO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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