Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, serum and plasma
Catalog Number
CD7156
Brand Name
Nano-CheckTM PCT plus
Version/Model Number
CD7156
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
65af3537-84df-498c-baee-ba88a3956a52
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-