DIFFTROL - Whole Blood Hematology Control - HORIBA INSTRUMENTS INCORPORATED

Duns Number:052845583

Device Description: Whole Blood Hematology Control

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More Product Details

Catalog Number

5300100147

Brand Name

DIFFTROL

Version/Model Number

24x3 mL

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)

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

JPK

Product Code Name

Mixture, Hematology Quality Control

Device Record Status

Public Device Record Key

73faa21c-79ff-4d0f-86b8-74c5c05b3e7d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HORIBA INSTRUMENTS INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14