BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

DrugCheck

DI: B298301100 · Model: 30110 · EXPRESS DIAGNOSTICS INT'L, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: DrugCheck
Primary DI: B298301100
Version / Model: 30110
Catalog Number: 30110
Company Name: EXPRESS DIAGNOSTICS INT'L, INC.
Labeler DUNS: 168560402
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-08-31
Public Version: 6
Public Version Date: 2022-12-20
Public Version Status: Update
Public Device Record Key: d8ef1e10-4962-42d6-93af-7316be5b275d
Distribution End Date: 2019-04-26

Device Description

Single Dip Drug Test, AMP

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55489	Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B298301100	HIBCC

Customer Contacts

Phone: 507-526-3951
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 2 – 30 Degrees Celsius