Duns Number:033305264
Device Description: The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing The MiSeqDx Universal Kit 1.0 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. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/515039485 MiSeqDx Universal Kit 1.0 1A15039488 MiSeqDx Universal Kit 1.0 1B15039492 MiSeqDx Universal Kit 1.0 2/515039498 MiSeqDx Universal Kit 1.0 3/515039494 MiSeqDx Universal Kit 1.0 3A15039496 MiSeqDx Universal Kit 1.0 3B15039500 MiSeqDx Universal Kit 1.0 4/515039503 MiSeqDx Universal Kit 1.0 5/5
Catalog Number
DX-103-1001
Brand Name
MiSeqDx Universal Kit 1.0
Version/Model Number
15038741
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN130042
Product Code
PFT
Product Code Name
Reagents For Molecular Diagnostic Test Systems
Public Device Record Key
fddb1e32-cea9-417b-90ca-23def8d73a3c
Public Version Date
August 11, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 1 |