EDDP CONTROL 1 - The Randox EDDP Control - Level 1 is intended for - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethy The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP.

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More Product Details

Catalog Number

DA3123

Brand Name

EDDP CONTROL 1

Version/Model Number

DA3123

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

K092258

Product Code Details

Product Code

DIF

Product Code Name

Drug Mixture Control Materials

Device Record Status

Public Device Record Key

a51e54c8-b020-4d74-8a60-57cd6425a465

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