2SAN Fentanyl Rapid Tes Cassette USFTY1AT-1

GUDID 06936983149310

1T,FDA, OTC,1ng

Hangzhou AllTest Biotech Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical
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

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