Noble Dip Card with AD (Urine)

Basic Information

• Brand Name: Noble Dip Card with AD (Urine)
• Primary DI: 10858886006763
• Version / Model: E-NMCardA-09-37-BT
• Company Name: NOBLE MEDICAL INC
• Labeler DUNS: 035967806
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-02-01
• Public Version: 1
• Public Version Date: 2023-02-09
• Public Version Status: New
• Public Device Record Key: d79ff6a3-72a6-414b-b679-f1dbb6c76493
• Distribution End Date: 2080-02-01

Device Description

AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/(OX/pH/SG)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
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
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
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	00858886006766	GS1
Primary	10858886006763	GS1