Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 10722066005641
• Version / Model: D12.36-1P29-25
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-05-11
• Public Version: 3
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: 6b7c62e6-927e-485b-80af-f8fa5b1ee743

Device Description

12- Drug Test Panel - 25/kit (12.36) - AMP1000 BAR300 BZO300 COC300 MDMA500 MET1000 OPI2000 PCP25 THC50 MTD300 OXY100 PPX300. For the detection of drugs in human 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
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	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	00722066005644	GS1
Primary	10722066005641	GS1