Catalog Number

-

Brand Name

ST AIA-PACK E2 CALIBRATOR SET

Version/Model Number

N/A

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

Yes

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

CHP

Product Code Name

Radioimmunoassay, Estradiol

Public Device Record Key

62532174-0a61-4232-9cf4-3fce59d6870b

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Package DI Number

14560189211282

Quantity per Package

6

Contains DI Package

04560189211285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-