DRI Oxycodone Assay - Microgenics Corporation

Duns Number:122153799

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More Product Details

Catalog Number

-

Brand Name

DRI Oxycodone Assay

Version/Model Number

100249

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040411

Product Code Details

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Device Record Status

Public Device Record Key

7b314cde-a33c-48c4-a25d-f15ed2ea7858

Public Version Date

June 05, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROGENICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 184
2 A medical device with a moderate to high risk that requires special controls. 279
U Unclassified 9