Rapid Response One Step DOA Cup

Basic Information

• Brand Name: Rapid Response One Step DOA Cup
• Primary DI: 00722066004500
• Version / Model: D10.14-1V
• Company Name: BTNX Inc
• Labeler DUNS: 251005005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2018-07-30
• Public Version: 5
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: d1e5fc62-9ac4-4112-bdd5-b3baa7380095

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown		U
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
NFT	Test, Amphetamine, Over The Counter	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	00722066004500	GS1
Unit of Use	00722066004517	GS1
Package	10722066004514	GS1		6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K180349	000