The following data is part of a De Novo classification by Illumina, Inc. with the FDA for Miseqdx Universal Kit 1.0.
| DeNovo ID | DEN130042 |
| Device Name: | MISEQDX UNIVERSAL KIT 1.0 |
| Classification | Reagents For Molecular Diagnostic Test Systems |
| Applicant | ILLUMINA, INC. 5200 Illumina Way San Diego, CA 92122 |
| Contact | Leanne M Kiviharju |
| Product Code | PFT |
| CFR Regulation Number | 862.3800 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K133136 |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2013-10-04 |
| Decision Date | 2013-11-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816270020040 | DEN130042 | 000 |