Multi-Drug 14 Drugs Rapid Test Cup

GUDID 16936983165478

FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1

Hangzhou AllTest Biotech Co., Ltd.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID16936983165478
NIH Device Record Key2d4d74fd-aa38-45e9-a251-1326fc028886
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Drug 14 Drugs Rapid 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
GS106936983165471 [Primary]
GS116936983165478 [Unit of Use]

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 Date2024-09-16
Device Publish Date2024-09-08

On-Brand Devices [Multi-Drug 14 Drugs Rapid Test Cup]

16936983165522FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1
16936983165478FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1

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