Duns Number:045361136
Device Description: The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in exam The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in examining the accuracy and precision of the quantitative Stanbio Procalcitonin (PCT) LiquiColor® Assay.
Catalog Number
2320-203
Brand Name
Procalcitonin (PCT) Bi-Level Controls
Version/Model Number
2320-203
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 30, 2022
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
-
Product Code
PTF
Product Code Name
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Public Device Record Key
95d04226-f658-4e7a-81a6-7bdbd7b35056
Public Version Date
August 31, 2022
Public Version Number
3
DI Record Publish Date
June 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |