Duns Number:019410187
Device Description: T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BAR, BUP, BZO, COC, MDMA, MET500, MOP, MTD, T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BAR, BUP, BZO, COC, MDMA, MET500, MOP, MTD, OXY, PCP, TCA, THC>
Catalog Number
-
Brand Name
T-Cup® Compact
Version/Model Number
ACDOA-10135
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182701
Product Code
LCM
Product Code Name
Enzyme Immunoassay, Phencyclidine
Public Device Record Key
6b8450c6-59ee-47d5-9540-252527694ff4
Public Version Date
October 31, 2022
Public Version Number
7
DI Record Publish Date
September 09, 2019
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. | 122 |
| U | Unclassified | 1 |