DEVICE: Healgen (Private Label) 6125A3 (00895330002851)

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Device Identifier (DI) Information
Healgen (Private Label) 6125A3
CB-HE-CUP-6125A3C
In Commercial Distribution

CONFIRM BIOSCIENCES, INC.
00895330002851
GS1

1
806524968 *Terms of Use
Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
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
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
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
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
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
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
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
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FDA Product Code

[?]
Product Code Product Code Name
NGL Test, Opiates, Over The Counter
NFT Test, Amphetamine, Over The Counter
PTH Test, Barbiturate, Over The Counter
NFV Test, Benzodiazepine, Over The Counter
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter
NGG Test, Methamphetamine, Over The Counter
PTG Test, Methadone, Over The Counter
NGM Test, Phencyclidine (Pcp), Over The Counter
NFW Test, Cannabinoid, Over The Counter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d7faa0be-f213-4af1-bc62-4f99104a78d7
December 20, 2022
6
January 19, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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