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510(k) Data Aggregation
K Number
K982311Device Name
BARTELS CINAKIT CMV ANTIGENEMIA
Manufacturer
INTRACEL CORP.
Date Cleared
1998-12-14
(166 days)
Product Code
GQH
Regulation Number
866.3175Why did this record match?
Product Code :
GQH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bartels CINAkit™ CMV Antigenemia Test is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the rapid direct qualitative detection of CMV pp65 antigen in human blood leukocytes by indirect immunofluorescence (IF). This product is not intended to be used for testing (i.e. screening) blood or plasma donors.
Device Description
BARTELS CINAKIT CMV Antigenemia is an indirect immunofluorescence test that allows detection of Human Cytomegalovirus antigen in leukocytes from peripheral blood. The test uses a monoclonal antibody pool (1C3, AYM-1) which recognizes the 65-68kDa lower matrix structural phosphoprotein (pp) (protein kinase, pp65, present in the nucleus of cells. The antibody pool (blended antibodies) recognizes two epitopes on the protein. Leukocytes are prepared from whole blood by dextran sedimentation and centrifugation; slides are prepared, fixed in formalin and permeabilized on detergent (NP40). Staining is accomplished with primary murine monoclonal antibodies to the pp65 antigen and F(Ab-)2 fluorescein-conjugated anti-mouse immunoglobulin secondary antibody. The slides are read using a fluorescence microscope.
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K Number
K964875Device Name
CMV ANTIGEN CONTROL SLIDES
Manufacturer
VIRAL ANTIGENS, INC.
Date Cleared
1997-03-18
(103 days)
Product Code
GQH
Regulation Number
866.3175Why did this record match?
Product Code :
GQH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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