2SAN Fentanyl Rapid Tes Cassette USFTY1AT-1

GUDID 06936983149310

1T,FDA, OTC,1ng

Hangzhou AllTest Biotech Co., Ltd.

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Primary Device ID06936983149310
NIH Device Record Key772fcb9f-36ac-41c0-a3bf-e5622f8463ed
Commercial Distribution StatusIn Commercial Distribution
Brand Name2SAN Fentanyl Rapid Tes Cassette
Version Model NumberDFY-A102H A2553
Catalog NumberUSFTY1AT-1
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
GS106936983149310 [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.

06936983148504 - Discover Fentanyl Rapid Tes Cassette2024-02-16 1T, cut-off:1ng/ml,FDA OTC
06936983149310 - 2SAN Fentanyl Rapid Tes Cassette2024-02-161T,FDA, OTC,1ng
06936983149310 - 2SAN Fentanyl Rapid Tes Cassette2024-02-16 1T,FDA, OTC,1ng
06936983149426 - Identify Fentanyl Rapid Cassette2024-02-16 1T,EN,FDA, OTC,1ng
06936983149433 - Identify Fentanyl Rapid Cassette2024-02-16 25T,EN,FDA clia waived,1ng
16936983150634 - Discover milti-drug 8 drugs rapid test cup (urine)2024-02-16 1T,MOP(OPI)300/OXY100/COC150/MET500/BAR300/BZO300/AMP500/BUP10+CRE/SG/PH,FDA clia waived
06936983143950 - Alltest 2023-12-08 Fentanyl Urine Test Cassette, 1T,FDA, OTC,1ng
06936983143370 - Alltest2023-12-08 Fentanyl Urine Test Cassette, 25T,FDA clia waived,1ng
06936983144551 - AllTest 2023-12-08 AllTest Fentanyl Urine Test Cassette, 25T (for FDA Clia Waived)1ng, White pouch

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