Duns Number:022637761
Device Description: SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal Cap, AMP, SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal Cap, AMP, BZO, COC, mAMP, OPI, THC, 25/BX
Catalog Number
-
Brand Name
REF
Version/Model Number
REF-EWCUP-264
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
d5dc1113-41f8-4edb-9cb9-f884949924c4
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 29, 2019
Package DI Number
00850798007749
Quantity per Package
4
Contains DI Package
00850798007732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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. | 3 |