DEVICE: CVS Health (00050428588697)
Device Identifier (DI) Information
CVS Health
346468
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
346468
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
14 Drugs Test Kit -
Marijuana (THC50), Cocaine (COC300), Methamphetamine (MET1000), Phencyclidine (PCP25), Opiates (OPI2000), Amphetamine (AMP1000), Ecstasy (MDMA500), Tricyclic Antidepressants (TCA1000), Barbiturates (BAR300), Benzodiazepines (BZO300), Methadone (MTD300), Oxycodone (OXY300), Propoxyphene (PPX300), Buprenorphine (BUP10)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 55570 | Cocaine/cocaine metabolite IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen.
|
Active | false |
| 55553 | Cannabinoid/cannabinoid metabolite IVD, reagent |
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.
|
Active | false |
| 55501 | Methamphetamine-specific IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen.
|
Active | false |
| 55749 | Phencyclidine (PCP) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen.
|
Active | false |
| 55724 | Opiate/opiate metabolite IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.
|
Active | false |
| 55489 | Amphetamine/methamphetamine 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 multiple drugs belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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 |
| 65385 | Buprenorphine 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 buprenorphine 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 |
| 55712 | Nortriptyline IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nortriptyline in a clinical specimen.
|
Active | false |
| 62324 | Propoxyphene/propoxyphene 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 propoxyphene/propoxyphene 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 |
| 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 |
| 55528 | Benzodiazepine group IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen.
|
Active | false |
| 55689 | Methadone IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of methadone in a clinical specimen.
|
Active | false |
| 55738 | Oxycodone IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of oxycodone in a clinical specimen.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| NFW | Test, Cannabinoid, Over The Counter |
| NGG | Test, Methamphetamine, Over The Counter |
| NGM | Test, Phencyclidine (Pcp), Over The Counter |
| NGL | Test, Opiates, Over The Counter |
| NFT | Test, Amphetamine, Over The Counter |
| QAW | Test, Tricyclic Antidepressants, Over The Counter |
| PTG | Test, Methadone, Over The Counter |
| QBF | Test, Propoxyphene, Over The Counter |
| PTH | Test, Barbiturate, Over The Counter |
| NFV | Test, Benzodiazepine, Over The Counter |
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
1af8b27a-739f-45bd-a1d4-b5a7a89c2c4f
December 20, 2022
6
December 03, 2020
December 20, 2022
6
December 03, 2020
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