DEVICE: Discover milti-drug12 drugs rapid test cup (16936983149751)
Device Identifier (DI) Information
Discover milti-drug12 drugs rapid test cup
DUA-A1127C-A3 A1617
In Commercial Distribution
DISP-DUD20125N$
Hangzhou AllTest Biotech Co., Ltd.
DUA-A1127C-A3 A1617
In Commercial Distribution
DISP-DUD20125N$
Hangzhou AllTest Biotech Co., Ltd.
1T,FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/BUP10+CRE/SG/PH
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| DNK | Thin Layer Chromatography, Morphine |
| DKZ | Enzyme Immunoassay, Amphetamine |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| DIS | Enzyme Immunoassay, Barbiturate |
| PTH | Test, Barbiturate, Over The Counter |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| DJC | Thin Layer Chromatography, Methamphetamine |
| NGL | Test, Opiates, Over The Counter |
| LAF | Gas Chromatography, Methamphetamine |
| LCM | Enzyme Immunoassay, Phencyclidine |
| NGI | Test, Morphine, Over The Counter |
| QAW | Test, Tricyclic Antidepressants, Over The Counter |
| NGG | Test, Methamphetamine, Over The Counter |
| DJR | Enzyme Immunoassay, Methadone |
| DJG | Enzyme Immunoassay, Opiates |
| LDJ | Enzyme Immunoassay, Cannabinoids |
| PTG | Test, Methadone, Over The Counter |
| NFW | Test, Cannabinoid, Over The Counter |
| NFV | Test, Benzodiazepine, Over The Counter |
| NFT | Test, Amphetamine, Over The Counter |
| NGM | Test, Phencyclidine (Pcp), Over The Counter |
| JXM | Enzyme Immunoassay, Benzodiazepine |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K182738 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c01ca7d9-9d4d-4f4f-8aca-320bb1a7a2be
February 19, 2024
1
February 09, 2024
February 19, 2024
1
February 09, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined