Alltest MOP2000 Home Rapid Test Panel(Urine)

Basic Information

• Brand Name: Alltest MOP2000 Home Rapid Test Panel(Urine)
• Primary DI: 06936983114752
• Version / Model: 1
• Catalog Number: DOP-A114H (2000ng)
• Company Name: Hangzhou AllTest Biotech Co., Ltd.
• Labeler DUNS: 543254717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-22
• Public Version: 1
• Public Version Date: 2026-04-30
• Public Version Status: New
• Public Device Record Key: 724ed831-a179-4d41-9aed-63cbdc15e40d

Device Description

1T, for FDA

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
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55701	Morphine/morphine 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 morphine and/or morphine 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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06936983114752	GS1

Premarket Submissions

Submission Number	Supplement Number
K182738	000