DrugCheck - 12 Panel Cup Drug Test, - EXPRESS DIAGNOSTICS INT'L, INC.

Duns Number:168560402

Device Description: 12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC

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More Product Details

Catalog Number

61200

Brand Name

DrugCheck

Version/Model Number

61200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2019

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

5ed61cd1-3f95-4af9-a319-f876cec34b78

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXPRESS DIAGNOSTICS 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. 522
U Unclassified 2