DEVICE: Identify® Diagnostics Drug Test Cards (10850721007546)
Device Identifier (DI) Information
Identify® Diagnostics Drug Test Cards
ID-CP6-DIP-AZ5
In Commercial Distribution
ID-CP6-DIP-AZ5
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ5
In Commercial Distribution
ID-CP6-DIP-AZ5
MEDICAL DISTRIBUTION GROUP INC
Identify® Diagnostics Drug Test Cards 6 panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LDJ | Enzyme Immunoassay, Cannabinoids |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
DJG | Enzyme Immunoassay, Opiates |
DJC | Thin Layer Chromatography, Methamphetamine |
JXM | Enzyme Immunoassay, Benzodiazepine |
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 |
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No Device Sizes |
Device Record Status
2a54143f-c508-468f-8ffe-e4380b2cab59
June 10, 2022
4
April 27, 2017
June 10, 2022
4
April 27, 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 |
---|---|---|---|---|---|
20850721007543 | 100 | 10850721007546 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00850721007549
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined