Alltest Multi-Drug 12 Drugs Rapid Test Cup

GUDID 16936983165447

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

Hangzhou AllTest Biotech Co., Ltd.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID16936983165447
NIH Device Record Key61d09659-9a1b-4ac0-a100-e83cacc18764
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlltest Multi-Drug 12 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
GS106936983165440 [Primary]
GS116936983165447 [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

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

16936983165416 - Multi-Drug 13 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/FYL1
16936983165447 - Alltest Multi-Drug 12 Drugs Rapid Test Cup2024-09-16FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
16936983165447 - Alltest Multi-Drug 12 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
16936983165454 - Alltest Multi-Drug 14 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
16936983165461 - Multi-Drug 12 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
16936983165478 - Multi-Drug 14 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
16936983165522 - Multi-Drug 14 Drugs Rapid Test Cup2024-09-16 FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1)+(OXI/CRE/pH)
06936983166256 - iScreen Urine Test DX Drug Screen Tox Cup2024-09-16 25T, FDA, CLIA WAIVED (AMP500/BAR300/BUP10/BZO300/COC150/FTY1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50)+(OXI/CRE/
06936983167116 - Shinetell Digital Pregnancy Test2024-09-16 1T, FDA OTC

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