AllTest Fentanyl Rapid Test (Urine)

GUDID 06936983136495

25T, 1ng

Hangzhou AllTest Biotech Co., Ltd.

Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical Fentanyl IVD, kit, rapid ICT, clinical
Primary Device ID06936983136495
NIH Device Record Key0acc81ba-fafd-4090-ad37-dd9f2a1a4dbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllTest Fentanyl Rapid Test (Urine)
Version Model NumberDFY-A102
Company DUNS543254717
Company NameHangzhou AllTest Biotech Co., Ltd.
Device Count25
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
GS106936983136495 [Primary]
GS106936983138840 [Unit of Use]

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 Date2023-08-30
Device Publish Date2023-08-22

On-Brand Devices [AllTest Fentanyl Rapid Test (Urine)]

0693698313885725T, 1ng,white package
0693698313649525T, 1ng

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.