Noble 1 Step Cup

Basic Information

• Brand Name: Noble 1 Step Cup
• Primary DI: 00858886006322
• Version / Model: NBCA-14A-PP
• Catalog Number: NBCA-14A-PP
• Company Name: NOBLE MEDICAL INC
• Labeler DUNS: 035967806
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2e14d661-10e5-41a2-8eb8-5081e0135fbf

Device Description

Drugs of Abuse Test Cup for THC50/C0C150/0PI300/mAMP500/AMP500/BZO300/BAR300/MTD300/MDMA500/OXY100/BUP10/TCA1000/PPX300/PCP25 + (Creatinine/Ni/pH/B1/S.G.)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
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	00858886006322	GS1

Premarket Submissions

Submission Number	Supplement Number
K122633	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius