Hemolysis and Wash Solution - Red Cell Lysing Reagent - TOSOH BIOSCIENCE, INC.

Duns Number:607696440

Device Description: Red Cell Lysing Reagent

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More Product Details

Catalog Number

-

Brand Name

Hemolysis and Wash Solution

Version/Model Number

018431US

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)

Yes

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

GGK

Product Code Name

Products, Red-Cell Lysing Products

Device Record Status

Public Device Record Key

7ca72db7-ca96-42bc-9d73-f446bc3bb06a

Public Version Date

June 08, 2018

Public Version Number

2

DI Record Publish Date

April 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOSOH BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 3