Duns Number:176458115
Device Description: Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for e Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, THC, OPI, PCP (cocaine, amphetamine, marijuana, opiates, Phencyclidine).
Catalog Number
-
Brand Name
SAFECUP II MULTIDRUG N5
Version/Model Number
45455
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
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
251b345e-5471-4c5f-a06a-730168116349
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
May 12, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |