Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 00722066004906
• Version / Model: D12.11.1-1VA
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 5
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: a3d47e5e-7613-4f3d-a334-9890661f6b76

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	862.3640	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00722066004906	GS1

Premarket Submissions

Submission Number	Supplement Number
K181768	000
K182738	000