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Found 59 results
510(k) Data Aggregation
K Number
K021162Device Name
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2002-08-30
(141 days)
Product Code
JPA
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Device Description
The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.
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K Number
K020109Device Name
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2002-02-06
(26 days)
Product Code
GGC
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Device Description
Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.
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K Number
K013549Device Name
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-12-26
(63 days)
Product Code
DAP
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing Ddimer in citrated human plasma in D-dimer agglutination assays.
Device Description
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma control that is suitable for use as a calibrator in the Sigma Diagnostics AUTO D-dimer assay. Sigma Diagnostics AUTO D-Dimer Calibrator is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Calibrator is stable for 3 days when stored at 2-8°C and 8 hours when stored at 18-26°C.
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K Number
K013544Device Name
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-11-15
(22 days)
Product Code
DAP
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Device Description
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as a elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay.
Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
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K Number
K013545Device Name
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-11-15
(22 days)
Product Code
DAP
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
Device Description
Sigma Diagnostics AUTO D-Dimer Control, Level 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
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K Number
K012410Device Name
INFINITY HBA KIT, MODELS 537-A, 537-B
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-10-26
(88 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers.
Sigma Diagnostics INFINITY™ HbA1c is a device to measure the percent hemoglobin A1c in anticoagulated whole blood. Hemoglobin A1c is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.
Device Description
The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.
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K Number
K010652Device Name
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-03-30
(25 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010158Device Name
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-03-22
(64 days)
Product Code
GGO
Regulation Number
864.7925Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003267Device Name
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-03-15
(148 days)
Product Code
DAP
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003328Device Name
ACCUCLOT CONTROL I, MODEL A4089
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2001-03-01
(128 days)
Product Code
GIZ
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
SIGMA DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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