Duns Number:075150847
Device Description: The Cotinine direct (Serum/Urine) ELISA is a specific and sensitive in-vitro test to detec The Cotinine direct (Serum/Urine) ELISA is a specific and sensitive in-vitro test to detect the presence of Cotinine in serum and urine.
Catalog Number
EIA-5497
Brand Name
Cotinine direct (serum/urine) ELISA (480 well)
Version/Model Number
EIA-5497
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
-
Product Code
MRS
Product Code Name
Test system, nicotine, cotinine, metabolites
Public Device Record Key
fd7eea38-c296-43de-960c-5c2f5be1c62f
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 2021
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |