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510(k) Data Aggregation
K Number
K062534Device Name
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
Manufacturer
DRG INTL., INC.
Date Cleared
2008-01-29
(518 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Applicant Name (Manufacturer) :
DRG INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K052649Device Name
DRG SLV TESTOSTERONE ELISA TEST
Manufacturer
DRG INTL., INC.
Date Cleared
2006-01-27
(123 days)
Product Code
CDZ
Regulation Number
862.1680Why did this record match?
Applicant Name (Manufacturer) :
DRG INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delaved or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
Device Description
The DRG Salivary Testosterone ELISA Kit is based on the competition princible and the microplate separation. An unknown amount of free testosterone present in the sample and a fixed amount of testosterone conjugated with horseradish peroxidase compete for the binding sites of mouse monoclonal testosterone -antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the substrate solution the concentration of testosterone is inversely proportional to the optical density measured.
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K Number
K051733Device Name
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
Manufacturer
DRG INTL., INC.
Date Cleared
2005-12-07
(162 days)
Product Code
NHG
Regulation Number
862.1205Why did this record match?
Applicant Name (Manufacturer) :
DRG INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Device Description
The DRG Salivary Cortisol ELISA KIT is based on the competition principle and the microplate separation. An unknown amount of Cortisol present in the sample and a fixed amount of Cortisol coniugated with horseradish peroxidase compete for the binding sites of mouse polyclonal Cortisol-antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the TMB substrate solution the concentration of Cortisol is inversely proportional to the optical density measured.
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K Number
K000043Device Name
DRG AURICA ELISA TESTOSTERONE KIT
Manufacturer
DRG INTL., INC.
Date Cleared
2000-04-17
(102 days)
Product Code
CDZ
Regulation Number
862.1680Why did this record match?
Applicant Name (Manufacturer) :
DRG INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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