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Found 23 results
510(k) Data Aggregation
K Number
K003054Device Name
AUTOSTAT II ENA-6 PROFILE ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-10-13
(11 days)
Product Code
LLL
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003057Device Name
AUTOSTAT II ENA-4 PROFILE ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-10-13
(11 days)
Product Code
LLL
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002215Device Name
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-09-28
(66 days)
Product Code
MOB
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993557Device Name
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-03-03
(135 days)
Product Code
DHR
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy. Tec Automated EIA instrument.
For in vitro diagnostic use only.
Device Description
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K Number
K994338Device Name
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-02-03
(42 days)
Product Code
DHR
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA. USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS . LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY
Device Description
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K Number
K993085Device Name
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-02-01
(139 days)
Product Code
MID
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the detection of IgG, IgM and 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 multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Not Found
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K Number
K993304Device Name
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
1999-12-06
(63 days)
Product Code
DHR
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgG assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Not Found
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K Number
K992449Device Name
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
1999-11-24
(125 days)
Product Code
MID
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to cardiolipin in human serum.
Uses:
The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid syndrome.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Not Found
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K Number
K993086Device Name
AUTOSTAT II ANTI-GLIADIN IGA ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
1999-11-12
(58 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS 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 gliadin in human serum.
Uses:
The results of the anti-gliadin IgA assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Not Found
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K Number
K993087Device Name
AUTOSTAT II ANTI-GLIADIN IGG ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
1999-11-12
(58 days)
Product Code
MST
Regulation Number
866.5750Why did this record match?
Applicant Name (Manufacturer) :
COGENT DIAGNOTICS 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 gliadin in human serum.
Uses:
The results of the anti-gliadin IgG assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease.
Levels of these antibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy•Tec Automated EIA instrument.
For in vitro diagnostic use only.
Device Description
Not Found
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