Duns Number:010551716
Device Description: COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED)
Catalog Number
10-300
Brand Name
Instant Test Cup
Version/Model Number
10-300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082898
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
6131e877-811e-4d87-a536-82d7e384f8e2
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
March 31, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |
| U | Unclassified | 1 |