DEVICE: Rapid Response (00722066003695)
Device Identifier (DI) Information
Rapid Response
D12.5-1T
In Commercial Distribution
D12.5-1T
BTNX Inc
D12.5-1T
In Commercial Distribution
D12.5-1T
BTNX Inc
Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 Tests/ kit are for the qualitative detection of Amphetamine, Barbiturate, Buprenorphine, Bezodiazepines, 3,4-Methylenedioxy-Methamphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Cocaine and THC metabolites in urine.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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 |
---|---|
LCM | Enzyme Immunoassay, Phencyclidine |
DIS | Enzyme Immunoassay, Barbiturate |
JXM | Enzyme Immunoassay, Benzodiazepine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
LDJ | Enzyme Immunoassay, Cannabinoids |
DJG | Enzyme Immunoassay, Opiates |
DJR | Enzyme Immunoassay, Methadone |
DKZ | Enzyme Immunoassay, Amphetamine |
DJC | Thin Layer Chromatography, Methamphetamine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121065 | 000 |
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
ad5fc687-6723-4698-a11e-7e6ad9853d9d
April 20, 2023
6
October 25, 2016
April 20, 2023
6
October 25, 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 |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00722066004098
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined