Exploro Highly Sensitive Urine Drug Test (14-Panel)

Basic Information

• Brand Name: Exploro Highly Sensitive Urine Drug Test (14-Panel)
• Primary DI: 06974246462424
• Version / Model: 10 tests
• Catalog Number: MULTID14-1
• Company Name: Safecare Biotech (Hangzhou) Co., Ltd.
• Labeler DUNS: 544349634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-30
• Public Version: 2
• Public Version Date: 2025-10-24
• Public Version Status: Update
• Public Device Record Key: 01f7fcc6-f0ab-46c9-984c-1a0322e68bd2

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
NFT	Test, Amphetamine, Over The Counter	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	06974246462424	GS1

Premarket Submissions

Submission Number	Supplement Number
K201120	000