QuickProfile™ Methadone Test Strip - Immunoassay for the detection of methadone in - LUMIQUICK DIAGNOSTICS, INC.

Duns Number:790175165

Device Description: Immunoassay for the detection of methadone in human urine

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


More Product Details

Catalog Number

07RD7019

Brand Name

QuickProfile™ Methadone Test Strip

Version/Model Number

07RD7019

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)

Yes

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

DJR

Product Code Name

Enzyme Immunoassay, Methadone

Device Record Status

Public Device Record Key

3f8cc680-5929-4164-8df3-79b760306ee2

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 15, 2017

Additional Identifiers

Package DI Number

M90107RD70191

Quantity per Package

50

Contains DI Package

M90107RD70190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK

"LUMIQUICK DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 117
U Unclassified 2