DOA - The Evidence® Drugs of Abuse (DOA) Assays are - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitativ The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays.

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More Product Details

Catalog Number

EV3500

Brand Name

DOA

Version/Model Number

EV3500

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

K030360,K050179,K043071,K041144,K041143,K041142,K040570,K040350

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

0ca14a85-7068-45a7-abb5-fc5e4c930bbb

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RANDOX LABORATORIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 258