Research and Diagnostic Systems - CBC-LINE Kit: 6 x 3mL (6 vials each of the - RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Duns Number:087248183

Device Description: CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7WBC Levels 1- CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7WBC Levels 1-3,5-7PLT Levels 1,4,6,9-11Low Levels 1-6

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More Product Details

Catalog Number

CL031

Brand Name

Research and Diagnostic Systems

Version/Model Number

CL031

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K942822

Product Code Details

Product Code

JPK

Product Code Name

Mixture, Hematology Quality Control

Device Record Status

Public Device Record Key

53cec46d-7962-4699-a579-3c300eb62bfd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESEARCH AND DIAGNOSTIC SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 135