DEVICE: Precision DX (00840050513156)
Device Identifier (DI) Information
Precision DX
PREDXDUD20124M
In Commercial Distribution
AMERICAN SCREENING, L.L.C.
PREDXDUD20124M
In Commercial Distribution
AMERICAN SCREENING, L.L.C.
No description.
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? |
|---|---|---|---|---|
| 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 |
|---|---|
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| NFT | Test, Amphetamine, Over The Counter |
| NFV | Test, Benzodiazepine, Over The Counter |
| NFW | Test, Cannabinoid, Over The Counter |
| NGG | Test, Methamphetamine, Over The Counter |
| NGL | Test, Opiates, Over The Counter |
| NGM | Test, Phencyclidine (Pcp), Over The Counter |
| PTG | Test, Methadone, Over The Counter |
| PTH | Test, Barbiturate, Over The Counter |
| QAW | Test, Tricyclic Antidepressants, Over The Counter |
| QBF | Test, Propoxyphene, Over The Counter |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K180349 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6871579d-091e-4e9e-8057-35a7d1526196
October 28, 2024
2
November 11, 2022
October 28, 2024
2
November 11, 2022
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined