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Found 4 results
510(k) Data Aggregation
K Number
K043433Device Name
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
Manufacturer
HYCOR BIOMEDICAL LTD.
Date Cleared
2005-03-07
(84 days)
Product Code
MVM
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
HYCOR BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Uses:
The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
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K Number
K033744Device Name
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
Manufacturer
HYCOR BIOMEDICAL LTD.
Date Cleared
2004-01-20
(50 days)
Product Code
MVM
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
HYCOR BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.
Uses:
The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Prescription Use (Per 21 CFR 801.109)
Device Description
Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.
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K Number
K030741Device Name
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
Manufacturer
HYCOR BIOMEDICAL LTD.
Date Cleared
2003-05-01
(52 days)
Product Code
MID
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
HYCOR BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.
Uses:
The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime.
This device can be used with the HYCOR HY•TEC automated EIA instrument.
For in vitro diagnostic use only.
Prescription use
Device Description
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.
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K Number
K030397Device Name
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
Manufacturer
HYCOR BIOMEDICAL LTD.
Date Cleared
2003-03-21
(43 days)
Product Code
MSV
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
HYCOR BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum.
Uses:
The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Not Found
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