Identify Fentanyl Rapid Cassette ID-AT1-DIP-FEN-1-AZ25

GUDID 06936983149433

25T,EN,FDA clia waived,1ng

Hangzhou AllTest Biotech Co., Ltd.

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Primary Device ID	06936983149433
NIH Device Record Key	57b7834c-e13f-41d8-b084-afd9cd0f67c5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Identify Fentanyl Rapid Cassette
Version Model Number	DFY-A102C A3218
Catalog Number	ID-AT1-DIP-FEN-1-AZ25
Company DUNS	543254717
Company Name	Hangzhou AllTest Biotech Co., Ltd.
Device Count	25
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936983149433 [Unit of Use]
GS1	16936983149430 [Primary]

FDA Product Code

DJG	Enzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-02-16
Device Publish Date	2024-02-08

On-Brand Devices [Identify Fentanyl Rapid Cassette]

06936983149433	25T,EN,FDA clia waived,1ng
06936983149426	1T,EN,FDA, OTC,1ng