DEVICE: u-Card Drug Test Screen (10817038021368)
Device Identifier (DI) Information
u-Card Drug Test Screen
U-DUD-6124L
In Commercial Distribution
U-DUD-6124L
UCP BIOSCIENCES, INC.
U-DUD-6124L
In Commercial Distribution
U-DUD-6124L
UCP BIOSCIENCES, INC.
12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC with Adulteration strip(S.G./CRE/ pH)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DJR | Enzyme Immunoassay, Methadone |
| DJC | Thin Layer Chromatography, Methamphetamine |
| DKZ | Enzyme Immunoassay, Amphetamine |
| DJG | Enzyme Immunoassay, Opiates |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| LDJ | Enzyme Immunoassay, Cannabinoids |
| JXM | Enzyme Immunoassay, Benzodiazepine |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8b9f6350-afd2-4600-b4da-74cfc72be8bb
June 10, 2022
4
January 20, 2017
June 10, 2022
4
January 20, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20817038021365 | 40 | 10817038021368 | In Commercial Distribution | case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
00817038021361
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined