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510(k) Data Aggregation
K Number
K961755Device Name
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
Manufacturer
Date Cleared
1996-05-17
(11 days)
Product Code
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
PROTEINS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Device Description
The CytoQuant™ Chlamydia Transport Medium (2SP) is widely recognized as an effective medium for chlamydia transport
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K Number
K961756Device Name
CYTOQUANT VIRAL TRANSPORT MEDIUM
Manufacturer
Date Cleared
1996-05-17
(11 days)
Product Code
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
PROTEINS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Device Description
microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory.
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Ask a specific question about this device
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