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510(k) DEN130042

MISEQDX UNIVERSAL KIT 1.0 by Illumina, Inc. — Product Code PFT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 19, 2013
Date Received
October 4, 2013
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents For Molecular Diagnostic Test Systems
Device Class
Class I
Regulation Number
862.3800
Review Panel
TX
Submission Type

A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.

Other clearances by Illumina, Inc.

  • K132750 — ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (November 19, 2013)
  • K124006 — ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (November 19, 2013)
  • DEN130011 — ILLUMINA MISEQDX PLATFORM (November 19, 2013)
  • K093128 — ILLUMINA BEADXPRESS SYSTEM (April 28, 2010)
  • K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (April 28, 2010)