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510(k) Data Aggregation
K Number
K083430Device Name
REAL-TIME PCR INTERNAL CONTROL 2B SET
Manufacturer
NANOGEN, INC.
Date Cleared
2009-01-15
(57 days)
Product Code
OLD
Regulation Number
862.1660Why did this record match?
Product Code :
OLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Real-Time PCR Internal Control 2B Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control 2B Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Device Description
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