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Found 6 results
510(k) Data Aggregation
K Number
K123763Device Name
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
Manufacturer
IMMUNODIAGNOSTIC SYSTEMS LTD.
Date Cleared
2013-12-24
(382 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Product Code :
CIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension.
The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.
Device Description
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K Number
K121944Device Name
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
Manufacturer
DIASORIN, INC.
Date Cleared
2013-01-01
(182 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Product Code :
CIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062120Device Name
CISBIO RENIN RIA TEST
Manufacturer
CIS BIO INTERNATIONAL
Date Cleared
2007-03-30
(248 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Product Code :
CIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A radioimmunoassay for the quantitative in vitro diagnostic measurement of the level of renin in plasma. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
Device Description
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K Number
K061758Device Name
ACTIVE RENIN IRMA
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
2006-07-28
(36 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Product Code :
CIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011128Device Name
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
Manufacturer
NICHOLS INSTITUTE DIAGNOSTICS
Date Cleared
2001-09-06
(146 days)
Product Code
CIB, JIT, JJX
Regulation Number
862.1085Why did this record match?
Product Code :
CIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981607Device Name
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
1998-05-27
(22 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Product Code :
CIB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
Device Description
The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.
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