One Step THC Rapid Urine Test Strips

GUDID 86942598206849

5T/bag; EN/SP

Hangzhou AllTest Biotech Co., Ltd.

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Primary Device ID86942598206849
NIH Device Record Key2183a5b9-226f-4a45-8aa6-a872e2c674be
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne Step THC Rapid Urine Test Strips
Version Model Number1
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106942598206843 [Primary]
GS186942598206849 [Unit of Use]

FDA Product Code

NFWTest, Cannabinoid, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

On-Brand Devices [One Step THC Rapid Urine Test Strips]

8694259820685610T/bag; EN/SP
869425982068495T/bag; EN/SP

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