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510(k) Data Aggregation
K Number
K010558Device Name
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
Manufacturer
Date Cleared
2001-04-03
(36 days)
Product Code
Regulation Number
866.5110Why did this record match?
Product Code :
MLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K991942Device Name
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
Manufacturer
Date Cleared
1999-08-24
(76 days)
Product Code
Regulation Number
866.5110Why did this record match?
Product Code :
MLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum.
Uses:
The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
For in vitro diagnostic use only.
Device Description
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GPC in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.
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