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510(k) Data Aggregation
K Number
K991268Device Name
GONOSTAT GONOCOCCAL DETECTION KIT
Manufacturer
Date Cleared
1999-08-11
(120 days)
Product Code
Regulation Number
866.3390Why did this record match?
Applicant Name (Manufacturer) :
SIERRA DIAGNOSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GONOSTAT® Gonococcal Detection Kit is indicated for the presumptive detection of Neisseria gonorrhoeae based on the detection of gonococcal DNA in female endocervical and male urethral specimens. Because of some cross-reactivity with DNA from N. meningitidis and some other members of the genus Neisseria, the test cannot be used with rectal or throat specimens.
Device Description
The device is a modification of the predicate device which is also marketed by Sierra Diagnostics, Inc. The device labeling was changed to reflect the results of additional clinical studies that support claims for the use of the device in low prevalence female populations.
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