DEVICE: Advin Multi-Drug Screen Test (B115ABCUP14011)

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Device Identifier (DI) Information

Advin Multi-Drug Screen Test
1
ABCup-14-01
ADVIN BIOTECH, INC.
B115ABCUP14011
HIBCC
25
AMP /BAR /BUP /BZO /COC /EDDP /MDMA /MET /MOR /MTD /OXY /PCP /TCA /THC
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

[?]
Product Code Product Code Name
DJG Enzyme Immunoassay, Opiates
LDJ Enzyme Immunoassay, Cannabinoids
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
LCM Enzyme Immunoassay, Phencyclidine
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
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 23, 2016
July 31, 2030
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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

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

[?]
Unit of Use DI Number: B115ABCUP14010 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(855)866-8382
info@advinbio.com
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