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Found 5 results
510(k) Data Aggregation
K Number
K964874Device Name
HSV-1 ANTIGEN CONTROL SLIDES
Manufacturer
VIRAL ANTIGENS, INC.
Date Cleared
1997-07-01
(208 days)
Product Code
GQN
Regulation Number
866.3305Why did this record match?
Applicant Name (Manufacturer) :
VIRAL ANTIGENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HSV-1 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-1. Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well. The two wells of cells on the HSV-1 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.
Device Description
Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well.
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K Number
K971101Device Name
HSV-2 ANTIGEN CONTROL SLIDES
Manufacturer
VIRAL ANTIGENS, INC.
Date Cleared
1997-07-01
(97 days)
Product Code
GQN
Regulation Number
866.3305Why did this record match?
Applicant Name (Manufacturer) :
VIRAL ANTIGENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HSV-2 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-2. Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well. The two wells of cells on the HSV-2 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.
Device Description
Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well.
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K Number
K964870Device Name
RSV ANTIGEN CONTROL SLIDES
Manufacturer
VIRAL ANTIGENS, INC.
Date Cleared
1997-03-18
(103 days)
Product Code
GQG
Regulation Number
866.3480Why did this record match?
Applicant Name (Manufacturer) :
VIRAL ANTIGENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964872Device Name
VZV ANTIGEN CONTROL SLIDES
Manufacturer
VIRAL ANTIGENS, INC.
Date Cleared
1997-03-18
(103 days)
Product Code
GQW
Regulation Number
866.3900Why did this record match?
Applicant Name (Manufacturer) :
VIRAL ANTIGENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Applicant Name (Manufacturer) :
VIRAL ANTIGENS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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