Duns Number:797393659
Device Description: Semi quantitative test for the detection of Cotinine (Nicotine Metabolite) in a Saliva spe Semi quantitative test for the detection of Cotinine (Nicotine Metabolite) in a Saliva specimen
Catalog Number
-
Brand Name
Accutest NicAlert Saliva Cotinine Test
Version/Model Number
DS43
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
K021688,K021688
Product Code
MRS
Product Code Name
Test System, Nicotine, Cotinine, Metabolites
Public Device Record Key
44513f8b-ed86-4402-8cab-2772659152c4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |