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510(k) Data Aggregation
K Number
K091969Device Name
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
Manufacturer
EUROIMMUN US INC
Date Cleared
2010-09-02
(428 days)
Product Code
NBO
Regulation Number
866.5660Why did this record match?
Product Code :
NBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
Device Description
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K Number
K000336Device Name
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
Manufacturer
RHIGENE, INC.
Date Cleared
2000-06-09
(127 days)
Product Code
NBO
Regulation Number
866.5660Why did this record match?
Product Code :
NBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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