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510(k) Data Aggregation
K Number
K113439Device Name
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
Manufacturer
EUROIMMUN US
Date Cleared
2013-04-12
(508 days)
Product Code
NIY, DBM, NBS, NRI, NUM
Regulation Number
866.5660Why did this record match?
Product Code :
NIY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) kit is an immune line-blot strip test intended for the qualitative detection of IgG class antibodies against 8 different antigens: AMA-M2, M2-3E (BPO), Sp100, PML, gp210, LKM-1, LC-1 and SLA/LP in human serum and plasma (EDTA, Li-heparin, Citrate). Detection of these antibodies is used as an aid in the diagnosis of autoimmune liver diseases in conjunction with other laboratory and clinical findings.
Device Description
The EUROIMMUN EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) consists of antigen coated test strips, a positive control, alkaline phosphatase-labelled anti-human 1gG conjugate, sample buffer, wash buffer concentrate, NBT/BCIP substrate solution tray, test instruction, evaluation protocol and reaction control card.
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K Number
K112221Device Name
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
Manufacturer
EUROIMMUN US
Date Cleared
2012-09-11
(406 days)
Product Code
NIY
Regulation Number
866.5660Why did this record match?
Product Code :
NIY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EUROIMMUN Anti-SLA/LP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLA/LP in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 1, in coniunction with other laboratory and clinical findings.
Device Description
The EUROIMMUN Anti-SLA/LP ELISA (IgG) consists of a microwell ELISA plate coated with SLA/LP antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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K Number
K021482Device Name
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2002-07-30
(83 days)
Product Code
NIY
Regulation Number
866.5660Why did this record match?
Product Code :
NIY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).
Device Description
The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA).
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