DrugCheck - Drug Check Single Dip Cassette Drug Test, MDMA - Express Diagnostic Int'l, Inc.

Duns Number:015875273

Device Description: Drug Check Single Dip Cassette Drug Test, MDMA

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

30190C

Brand Name

DrugCheck

Version/Model Number

30190C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LAF

Product Code Name

Gas Chromatography, Methamphetamine

Device Record Status

Public Device Record Key

f11c67c8-d64f-4c55-ae6f-4932fcb41aab

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXPRESS DIAGNOSTIC INT'L, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 286
U Unclassified 2