Search Results
Found 3 results
510(k) Data Aggregation
K Number
K992587Device Name
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
Manufacturer
STELLAR BIO SYSTEMS, INC.
Date Cleared
1999-12-22
(142 days)
Product Code
LSE
Regulation Number
866.3235Why did this record match?
Applicant Name (Manufacturer) :
STELLAR BIO SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Early Antigen (EBV-EA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum. The test detects IgG antibodies to both the diffuse (D) and restricted (R) components of the EBV early antigen complex. The EBV-EA IFA Test Kit should be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen (EBNA), and heterophile antibody) as an aid in the diagnosis of infectious mononucleosis (IM).
Device Description
The Epstein-Barr Virus Early Antigen (EBV-EA) IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to EBV-EA in human serum.
Ask a Question
K Number
K990915Device Name
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
Manufacturer
STELLAR BIO SYSTEMS, INC.
Date Cleared
1999-04-21
(34 days)
Product Code
DHN
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
STELLAR BIO SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases.
Device Description
The ANA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to ANA antigens in human serum.
Ask a Question
K Number
K990916Device Name
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
Manufacturer
STELLAR BIO SYSTEMS, INC.
Date Cleared
1999-04-21
(34 days)
Product Code
KTL
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
STELLAR BIO SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Anti-native DNA (nDNA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to nDNA in human serum. Detection of nDNA IgG antibody in humans can be used as an aid in the diagnosis of systemic lupus erythematosus (SLE).
Device Description
The nDNA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to nDNA antigen in human serum.
Ask a Question
Page 1 of 1