VERDICT®-II - A qualitative one-step immunochromatographic test - MEDTOX DIAGNOSTICS, INC.

Duns Number:137417965

Device Description: A qualitative one-step immunochromatographic test for the detection of Opiates and/or meta A qualitative one-step immunochromatographic test for the detection of Opiates and/or metabolites in human urine.

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More Product Details

Catalog Number

-

Brand Name

VERDICT®-II

Version/Model Number

601586

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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

K003687,K982211,K003687,K982211

Product Code Details

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Device Record Status

Public Device Record Key

4028178c-a5a0-4399-890c-7514db94f577

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10690286000121

Quantity per Package

25

Contains DI Package

00690286000124

Package Discontinue Date

February 28, 2021

Package Status

Not 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