Duns Number:401656868
Device Description: UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the conc UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentrationof intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum.
Catalog Number
67034
Brand Name
UniQ® PINP RIA
Version/Model Number
67034
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043125
Product Code
CIN
Product Code Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Public Device Record Key
518894c3-2a06-4e78-8ab9-2a18cb6ede20
Public Version Date
March 02, 2020
Public Version Number
5
DI Record Publish Date
April 13, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |