Prime Screen

Basic Information

• Brand Name: Prime Screen
• Primary DI: 00816862024456
• Version / Model: DCDOA-6125-5BX-A
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-05-22
• Public Version: 3
• Public Version Date: 2024-12-23
• Public Version Status: Update
• Public Device Record Key: 8053b2e9-3084-49a0-9e80-d65384de477a

Device Description

Prime Screen® Multi-Drug Urine Test Cup( 12-Panel C-Cup: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC), 5Test/ 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: 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
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	862.3150	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	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
Package	10816862024453	GS1		18	In Commercial Distribution
Primary	00816862024456	GS1
Unit of Use	00816862024463	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182701	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius