Duns Number:803126320
Device Description: The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposabl The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
Catalog Number
-
Brand Name
T2Candida® 1.1 Cartridge Kit
Version/Model Number
90-07817
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
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
PII
Product Code Name
Candida Species Nucleic Acid Detection System
Public Device Record Key
4221656f-1ae6-4638-9a46-30eba500aafc
Public Version Date
July 26, 2018
Public Version Number
1
DI Record Publish Date
June 25, 2018
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 |