Catalog Number

10225-4

Brand Name

UALB Reagent Kit

Version/Model Number

10225-4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K101089

Product Code

DCF

Product Code Name

Albumin, Antigen, Antiserum, Control

Public Device Record Key

1c3ed15f-dec8-40b7-a432-0638194495cb

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-