Eurotrol - Assayed Quality control solution - Eurotrol B.V.

Duns Number:412925992

Device Description: Assayed Quality control solution

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More Product Details

Catalog Number

139.002.002

Brand Name

Eurotrol

Version/Model Number

139.002.002

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

-

Prescription Use (Rx)

-

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

GGM

Product Code Name

Control, Hemoglobin

Device Record Status

Public Device Record Key

c66f486d-700f-4261-a4bb-6a4a86ce7f25

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EUROTROL B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 15