Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 10722066005368
• Version / Model: D12.8.1-1P29-25
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-03-21
• Public Version: 3
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: de19b824-d2c7-401e-9749-24cad0c30a04

Device Description

Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO/PCP/PPX) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Cocaine, THC, Phencyclidine and Propoxyphene metabolites in urine.

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
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
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
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	862.3700	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
Unit of Use	00722066005361	GS1
Primary	10722066005368	GS1

Premarket Submissions

Submission Number	Supplement Number
K181768	000