QuickProfile™ Drugs of Abuse Panel 10 Test - Immunoassay for the detection of the following - LUMIQUICK DIAGNOSTICS, INC.

Duns Number:790175165

Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC

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More Product Details

Catalog Number

07RD7073-04

Brand Name

QuickProfile™ Drugs of Abuse Panel 10 Test

Version/Model Number

07RD7073-04

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

c4e3b2c8-f137-4391-ba6a-4d6ca17cc307

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 15, 2017

Additional Identifiers

Package DI Number

M90107RD7073041

Quantity per Package

25

Contains DI Package

M90107RD7073040

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