510(k) DEN130042
DEN130042 is an FDA 510(k) premarket notification submitted by Illumina, Inc. for the device "MISEQDX UNIVERSAL KIT 1.0". The FDA issued a decision of De Novo Granted on November 19, 2013. The device falls under product code PFT (Reagents For Molecular Diagnostic Test Systems), a Class I device regulated under 21 CFR 862.3800. Illumina, Inc. has at least 5 other 510(k) clearances on record.
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.