Rapid Response

Basic Information

• Brand Name: Rapid Response
• Primary DI: 10722066006624
• Version / Model: D10.3.2-2FC1E
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 2
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: db5042e6-7906-40aa-88b6-69d8b485c1d5

Device Description

Rapid Response 10 Panel Saliva Test Cup E/I Screening (D10.3.2-2FC1E)- THC40, COC20, OPI40, AMP50, MET50, BAR50, BZO10, MDMA50, MTD30, PPX50. For employment and insurance testing.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
PVI	Test, Propoxyphene, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3700	2
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3100	2
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3150	2
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3170	2
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3250	2
PVB	Test, Codeine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3270	2
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3610	2
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3620	2
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3630	2
PVK	Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3910	2
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3870	2
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3640	2
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3650	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	00722066006627	GS1
Primary	10722066006624	GS1