DEVICE: Rapid Response (00722066004906)

Device Identifier (DI) Information

Rapid Response
D12.11.1-1VA
In Commercial Distribution

BTNX Inc
00722066004906
GS1

1
251005005 *Terms of Use
One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NGL Test, Opiates, Over The Counter
PTG Test, Methadone, Over The Counter
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter
PTH Test, Barbiturate, Over The Counter
NFW Test, Cannabinoid, Over The Counter
NFT Test, Amphetamine, Over The Counter
NGG Test, Methamphetamine, Over The Counter
NFV Test, Benzodiazepine, Over The Counter
DJG Enzyme Immunoassay, Opiates
DNK Thin Layer Chromatography, Morphine
DJR Enzyme Immunoassay, Methadone
DIS Enzyme Immunoassay, Barbiturate
LDJ Enzyme Immunoassay, Cannabinoids
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DKZ Enzyme Immunoassay, Amphetamine
DJC Thin Layer Chromatography, Methamphetamine
JXM Enzyme Immunoassay, Benzodiazepine
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K181768 000
K182738 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a3d47e5e-7613-4f3d-a334-9890661f6b76
April 20, 2023
5
October 16, 2019
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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