UScreen Oral

Basic Information

• Brand Name: UScreen Oral
• Primary DI: 00850065976280
• Version / Model: USSORAL-5NT-EUO
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Labeler DUNS: 554534314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2024-09-27
• Public Version: 1
• Public Version Date: 2024-10-07
• Public Version Status: New
• Public Device Record Key: 0844a914-fd63-4f03-b9b0-f23a51e61040

Device Description

UScreen Oral® Saliva Drug Test Pen, 5 Panel, 25T/Box

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: Yes
• 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
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	862.3220	1
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3870	2
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3620	2
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3610	2
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30516	Amphetamine-specific 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 a specific amphetamine 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
30517	Barbiturate 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 barbiturates 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
30518	Benzodiazepine group 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 benzodiazepine 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
30519	Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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
30520	Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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
30521	Methadone 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 methadone 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
30522	Opiate/opiate metabolite 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 opiate and/or opiate metabolites 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
55498	Methamphetamine-specific 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 a specific methamphetamine 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
64155	Cotinine 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 cotinine (nicotine metabolite) 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 to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). 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	30850065976281	GS1
Primary	00850065976280	GS1