Duns Number:033305264
Device Description: The TruSight Cystic Fibrosis Library Prep™ is a library preparation kit that supports the The TruSight Cystic Fibrosis Library Prep™ is a library preparation kit that supports the TruSight CysticFibrosis 139-Variant Assay™ and the TruSight Cystic Fibrosis Clinical Sequencing Assay™.The TruSight Cystic Fibrosis Library Preparation is an IVD kit constisting of the individual boxes listed below, which are all labeled with the same Device Identifier:20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035691, TruSight™ Cystic Fibrosis Library Prep 1A;20035692, TruSight™ Cystic Fibrosis Library Prep 1B; 20035693, TruSight™ Cystic Fibrosis Library Prep 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep 3/3;20035695, TruSight™ Cystic Fibrosis Library Prep 3A;20035696, TruSight™ Cystic Fibrosis Library Prep 3B.
Catalog Number
20036925
Brand Name
TruSight™ Cystic Fibrosis Library Preparation
Version/Model Number
20036925
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 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"
Yes
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
-
Product Code
PFR
Product Code Name
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Public Device Record Key
5234fc51-bcdc-41f4-ba5b-ca8f217e255a
Public Version Date
April 17, 2020
Public Version Number
1
DI Record Publish Date
April 09, 2020
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 |