Catalog Number

-

Brand Name

Hemolysate Reagent

Version/Model Number

5127

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GKA

Product Code Name

ABNORMAL HEMOGLOBIN QUANTITATION

Public Device Record Key

e2d82f6e-a544-4c3b-ae67-8397422b586b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-