EZ-SCREEN® CUP - A qualitative one-step immunochromatographic test - MEDTOX DIAGNOSTICS, INC.

Duns Number:137417965

Device Description: A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabin A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or their metabolites in human urine.

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More Product Details

Catalog Number

-

Brand Name

EZ-SCREEN® CUP

Version/Model Number

605102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100951,K002331,K050394,K060351,K100951,K010226,K060351,K050394,K010226,K002331

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

78685363-1a66-4949-b97d-d36419fbab28

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10690286000435

Quantity per Package

25

Contains DI Package

00690286000438

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit Box

"MEDTOX DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 36