QMS Everolimus Assay - Microgenics Corporation

Duns Number:122153799

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More Product Details

Catalog Number

-

Brand Name

QMS Everolimus Assay

Version/Model Number

10015987

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

K122766

Product Code Details

Product Code

OUF

Product Code Name

Everolimus Immunoassay

Device Record Status

Public Device Record Key

5e02efe4-7d93-4165-9449-a7f9a8742e3a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 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