510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130042Unknown

Miseqdx Universal Kit 1.0

Illumina, Inc., San Diego CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130042 is the FDA 510(k) clearance record for MISEQDX UNIVERSAL KIT 1.0, a class I device, cleared for Illumina, Inc. on under FDA product code PFT (Reagents For Molecular Diagnostic Test Systems). FDA's definition for product code PFT reads: "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...". FDA records list 6 510(k) clearances for Illumina, Inc., from to . As of , FDA records show no recalls naming DEN130042.

Clearance record

Decision date
Received
(46 days to decision)
Product code
PFT Reagents For Molecular Diagnostic Test Systems
Regulation
21 CFR 862.3800
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Illumina, Inc. 5200 Illumina Way, San Diego CA
Third party review
No

Clearances, product code PFT

Trailing 12 months

FDA records hold no clearances under product code PFT in the trailing twelve months.

FDA records show no clearances under product code PFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260