Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 00722066005507
• Version / Model: D6.6.2-1V
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-10
• Public Version: 3
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: 11a2ad63-c91b-4c4f-81e1-ab70fad806b1

Device Description

Rapid Response Drug Screening Cup (6.6.2) - AMP500 COC150 THC50 PCP25 MET500 OPI300

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown		U
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	862.3640	2
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	862.3640	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	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	00722066005507	GS1

Premarket Submissions

Submission Number	Supplement Number
K182738	000