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510(k) Data Aggregation
K Number
K021793Device Name
EBV EA-D IGG ELISA KIT, MODEL EBG-100
Manufacturer
Date Cleared
2002-09-27
(119 days)
Product Code
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
PAN BIO PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Epstein Barr Virus Early Diffuse Antigen (EBV EA-D) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV EA-D as an aid in the diagnosis of EBV infection in patients with clinical symptoms of Infectious Mononucleosis (IM). The PANBIO EBV EA-D IgG ELISA should be used in conjunction with other EBV serologies.
Device Description
The EBV EA-D IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV EA-D antigen in human serum.
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K Number
K020706Device Name
EBV-VCA IGG ELISA TEST, MODEL EBG-100
Manufacturer
Date Cleared
2002-06-13
(101 days)
Product Code
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
PAN BIO PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Epstein Barr Virus Viral Capsid Antigen (EBV-VCA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV-VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV-VCA IgG ELISA should be used in conjunction with other EBV serologies.
Device Description
The EBV-VCA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-VCA antigen in human serum.
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K Number
K020707Device Name
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
Manufacturer
Date Cleared
2002-06-13
(101 days)
Product Code
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
PAN BIO PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBNA IgG ELISA should be used in conjunction with other EBV serologies.
Device Description
The EBV-EBNA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-EBNA antigen in human serum.
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K Number
K020717Device Name
EBV V VCA IGM ELISA KIT MODEL# EBM-200
Manufacturer
Date Cleared
2002-06-13
(100 days)
Product Code
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
PAN BIO PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV VCA IgM ELISA should be used in conjunction with other EBV serology.
Device Description
The EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to EBV-VCA antigen in human serum.
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