Duns Number:137417965
Device Description: A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, and Benzodiazepines drugs and/or metabolites in human urine.
Catalog Number
-
Brand Name
PROFILE-II ER®
Version/Model Number
601591
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
K982211,K010138,K002331,K982211,K010138,K002331
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
8d3cd3a6-bc13-454e-9cf8-a05d0abe5720
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
10690286000275
Quantity per Package
25
Contains DI Package
00690286000278
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
kit box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |