Duns Number:803126320
Device Description: Instrument is a multiplex instrument that uses molecular amplification and magnetic resona Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
Catalog Number
-
Brand Name
T2Dx®
Version/Model Number
70-04933
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
DEN140019
Product Code
NSU
Product Code Name
Instrumentation For Clinical Multiplex Test Systems
Public Device Record Key
d79278b6-8e36-4a3f-b952-afe946d12144
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
February 12, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |