DrugCheck - Single Dip Drug Test, AMP500 - Express Diagnostic Int'l, Inc.

Duns Number:015875273

Device Description: Single Dip Drug Test, AMP500

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More Product Details

Catalog Number

30115

Brand Name

DrugCheck

Version/Model Number

30115

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

NFT

Product Code Name

Test, Amphetamine, Over The Counter

Device Record Status

Public Device Record Key

8e95734e-4b3b-4fb8-aa77-d89a20d8ab38

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 27, 2019

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