DEVICE: Amphetamine/Cocaine/Morphine Quick Cup (06952804801434)
Device Identifier (DI) Information
Amphetamine/Cocaine/Morphine Quick Cup
1.0
In Commercial Distribution
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
ASSURE TECH. (HANGZHOU) CO., LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
Yes | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Amphetamine-specific 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 a specific amphetamine 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. |
Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an immunochromatographic test (ICT) method. |
Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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 |
---|---|
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
DJG | Enzyme Immunoassay, Opiates |
DKZ | Enzyme Immunoassay, Amphetamine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
fdb4b6a7-0aeb-407b-8bd4-1f6f4ea61b52
March 29, 2018
2
February 06, 2017
March 29, 2018
2
February 06, 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 |
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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