DEVICE: UScreen Oral (00850065976280)
Device Identifier (DI) Information
UScreen Oral
USSORAL-5NT-EUO
In Commercial Distribution
Guangzhou Decheng Biotechnology Co., LTD
USSORAL-5NT-EUO
In Commercial Distribution
Guangzhou Decheng Biotechnology Co., LTD
UScreen Oral® Saliva Drug Test Pen, 5 Panel, 25T/Box
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 30516 | Amphetamine-specific 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 a specific amphetamine 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 |
| 30517 | Barbiturate 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 barbiturates 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 |
| 30520 | Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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 |
| 30519 | Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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 |
| 30521 | Methadone 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 methadone 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 |
| 30522 | Opiate/opiate metabolite 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 opiate and/or opiate metabolites 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 |
| 55498 | Methamphetamine-specific 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 a specific methamphetamine 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 |
| 30518 | Benzodiazepine group 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 benzodiazepine 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 |
| 64155 | Cotinine 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 cotinine (nicotine metabolite) 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 to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). It is not intended to be used for self-testing.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt |
| PUY | Test, Barbiturate, Employment And Insurance Testing, Exempt |
| PUZ | Test, Benzodiazepine, Employment And Insurance Testing, Exempt |
| PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
| MRS | Test System, Nicotine, Cotinine, Metabolites |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt |
| PVE | Test, Methadone, Employment And Insurance Testing, Exempt |
| PVD | Test, Methamphetamine, Employment And Insurance Testing, Exempt |
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
0844a914-fd63-4f03-b9b0-f23a51e61040
October 07, 2024
1
September 27, 2024
October 07, 2024
1
September 27, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
30850065976281
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined