DEVICE: Healgen (Private Label) - 564 (00895330002967)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Healgen (Private Label) - 564
CB-HE-564
In Commercial Distribution

CONFIRM BIOSCIENCES, INC.
00895330002967
GS1

1
806524968 *Terms of Use
Healgen (DrugConfirm) - 6 Panel Dip Test: BZO300/COC300/mAMP1000/MOP2000/OXY100/THC50
CLOSE

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?
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
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
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
CLOSE

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
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
94c9a056-b036-4cf3-b5a9-1e3312aef7da
December 27, 2022
1
December 19, 2022
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE