Discover Fentanyl Rapid Tes Cassette DISP-FY-102H

GUDID 06936983148504

1T, cut-off:1ng/ml,FDA OTC

Hangzhou AllTest Biotech Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical
Primary Device ID06936983148504
NIH Device Record Keya855d473-27ea-4064-8d05-4a76c4e3915b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiscover Fentanyl Rapid Tes Cassette
Version Model NumberDFY-A102H A1617
Catalog NumberDISP-FY-102H
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106936983148504 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-16
Device Publish Date2024-02-08

Devices Manufactured by Hangzhou AllTest Biotech Co., Ltd.

06936983168649 - DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup2025-02-21 FDA Clia Waived, 25T, MOP300/MDMA500/OXY100/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/THC50/BUP10/FYL1 + (OXI/SG
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 Cup2024-09-16 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/
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.