DEVICE: Advin Multi-Drug Screen Test (B115ABCUP10191)
Device Identifier (DI) Information
Advin Multi-Drug Screen Test
1
In Commercial Distribution
ABCup-10-19
ADVIN BIOTECH, INC.
1
In Commercial Distribution
ABCup-10-19
ADVIN BIOTECH, INC.
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
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 |
---|---|
DJG | Enzyme Immunoassay, Opiates |
LDJ | Enzyme Immunoassay, Cannabinoids |
DJR | Enzyme Immunoassay, Methadone |
DJC | Thin Layer Chromatography, Methamphetamine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
JXM | Enzyme Immunoassay, Benzodiazepine |
DIS | Enzyme Immunoassay, Barbiturate |
DKZ | Enzyme Immunoassay, Amphetamine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K122809 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9dec75b3-2aa1-4b2c-bc5b-1e9dafa2e4af
June 10, 2022
5
August 23, 2016
June 10, 2022
5
August 23, 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:
B115ABCUP10190
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(855)866-8382
info@advinbio.com
info@advinbio.com