Catalog Number

8525-300D

Brand Name

Monobind AccuBind AFP, hCG & uE3 VAST ELISA Kit - 480 Wells

Version/Model Number

8525-300

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LOJ

Product Code Name

KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Public Device Record Key

2d1b5f62-17c0-4e2f-ac24-0707a4610b9c

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-