Duns Number:122153799
Catalog Number
-
Brand Name
DRI Cotinine Calibrator Kit
Version/Model Number
0404
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
MKU
Product Code Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Public Device Record Key
55e2c689-d064-447e-90e2-e8a3834428a4
Public Version Date
July 09, 2019
Public Version Number
4
DI Record Publish Date
September 22, 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 | 184 |
2 | A medical device with a moderate to high risk that requires special controls. | 279 |
U | Unclassified | 9 |