Catalog Number

10998577

Brand Name

ADVIA Centaur® AFP

Version/Model Number

10998577

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 19, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P930036,P930036,P930036

Product Code

LOK

Product Code Name

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Public Device Record Key

85efaa57-9104-4d9b-ac42-9490ab8019c1

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

July 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-