DEVICE: Healgen (Private Label) FLATCUP-6125A3 (00895330002844)
Device Identifier (DI) Information
Healgen (Private Label) FLATCUP-6125A3
CB-HE-FLATCUP-6125A3C
In Commercial Distribution
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-6125A3C
In Commercial Distribution
CONFIRM BIOSCIENCES, INC.
12 Panel Flat-Cup w/ADU (AMP/COC/OXY/THC/PCP/MDMA/MOR/BZO/BAR/MTD/mAMP/BUP+A3)
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? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DIS | Enzyme Immunoassay, Barbiturate |
DJG | Enzyme Immunoassay, Opiates |
DJR | Enzyme Immunoassay, Methadone |
LCM | Enzyme Immunoassay, Phencyclidine |
LAF | Gas Chromatography, Methamphetamine |
DJF | Gas Chromatography, Opiates |
DKZ | Enzyme Immunoassay, Amphetamine |
JXM | Enzyme Immunoassay, Benzodiazepine |
DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
DJC | Thin Layer Chromatography, Methamphetamine |
DKE | Reagents, Test, Tetrahydrocannabinol |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1ef147a9-34bd-4d0d-9804-bc46ed5343a4
June 10, 2022
4
January 19, 2017
June 10, 2022
4
January 19, 2017
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 |
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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