DEVICE: DrugCheck (B298307520)
Device Identifier (DI) Information
DrugCheck
30752
In Commercial Distribution
30752
EXPRESS DIAGNOSTICS INT'L, INC.
30752
In Commercial Distribution
30752
EXPRESS DIAGNOSTICS INT'L, INC.
7 Panel Dip Drug Test, AMP-BUP-BZO-COC-MTD-OPI300-OXY
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DKZ | Enzyme Immunoassay, Amphetamine |
JXM | Enzyme Immunoassay, Benzodiazepine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
DJR | Enzyme Immunoassay, Methadone |
DJG | Enzyme Immunoassay, Opiates |
LAF | Gas Chromatography, Methamphetamine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
583a9e78-4e9e-418b-ba6e-2301fbfbe18d
March 29, 2018
2
September 12, 2016
March 29, 2018
2
September 12, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
507-526-3951
quality@drugcheck.com
quality@drugcheck.com