DEVICE: Healgen (Private Label) - 654 (00895330002646)
Device Identifier (DI) Information
Healgen (Private Label) - 654
CB-HE-654
In Commercial Distribution
CONFIRM BIOSCIENCES, INC.
CB-HE-654
In Commercial Distribution
CONFIRM BIOSCIENCES, INC.
Healgen (DrugConfirm) - 5 Panel Dip Card - CLIA Waived - BZO300/COC300/mAMP1000/MOP2000/THC50
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NFV | Test, Benzodiazepine, Over The Counter |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| NGG | Test, Methamphetamine, Over The Counter |
| NGL | Test, Opiates, Over The Counter |
| NFW | Test, Cannabinoid, 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
1a82dbd4-a624-4552-9ee5-837a834d3c77
December 19, 2022
5
September 07, 2016
December 19, 2022
5
September 07, 2016
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