DEVICE: SURE-SCREEN® (00690286000407)
Device Identifier (DI) Information
SURE-SCREEN®
600723
Not in Commercial Distribution
MEDTOX DIAGNOSTICS, INC.
600723
Not in Commercial Distribution
MEDTOX DIAGNOSTICS, INC.
A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and THC (cannabinoids) drugs and/or their metabolites in human urine.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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 |
---|---|
JXN | Enzyme Immunoassay, Propoxyphene |
DIS | Enzyme Immunoassay, Barbiturate |
DJR | Enzyme Immunoassay, Methadone |
JXM | Enzyme Immunoassay, Benzodiazepine |
DKZ | Enzyme Immunoassay, Amphetamine |
DJG | Enzyme Immunoassay, Opiates |
DJC | Thin Layer Chromatography, Methamphetamine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
LCM | Enzyme Immunoassay, Phencyclidine |
LDJ | Enzyme Immunoassay, Cannabinoids |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K002331 | 000 |
K010226 | 000 |
K020787 | 000 |
K050394 | 000 |
K060351 | 000 |
K100951 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d3a7cf32-42b3-448d-9e0c-e2179a1c7df1
June 10, 2022
7
September 16, 2016
June 10, 2022
7
September 16, 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 |
---|---|---|---|---|---|
10690286000404 | 25 | 00690286000407 | 2020-10-31 | Not in Commercial Distribution | kit box |
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
[?]
877-643-5703
techservices@medtoxdiagnostics.com
techservices@medtoxdiagnostics.com