DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup

GUDID 06936983168649

FDA Clia Waived, 25T, MOP300/MDMA500/OXY100/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/THC50/BUP10/FYL1 + (OXI/SG/PH)+(NIT/GLU/CRE)

Hangzhou AllTest Biotech Co., Ltd.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID06936983168649
NIH Device Record Key1e387a89-ffe5-4dc5-bc96-ded40e648ac9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup
Version Model Number1
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count25
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106936983168649 [Unit of Use]
GS116936983168646 [Primary]

FDA Product Code

NFTTest, Amphetamine, 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 Date2025-02-21
Device Publish Date2025-02-13

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

16942598201647 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Rapid Test Cup, OTC (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD30
06942598201657 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Rapid Test Cup, OTC (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD30
06942598201664 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Rapid Test Cup, OTC (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD30
06942598201671 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Test Cup, CLIA WAIVED (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD
06942598201688 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Test Cup, CLIA WAIVED (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD
06942598201695 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Test Cup, CLIA WAIVED (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD
06942598201701 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Test Cup, CLIA WAIVED (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD
06942598201718 - DrugTect Multi-Drug Rapid Test Cup2025-11-24 DrugTect, 14 Panel Multi-Drug Test Cup, CLIA WAIVED (AMP500, BAR300, BUP10, BZO300, COC150, FYL1, MDMA500, MET500, MOP300, MTD

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