Catalog Number

-

Brand Name

Lumipulse G E2-III Immunoreaction Cartridges

Version/Model Number

235171

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 18, 2018

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

-

Product Code

CHP

Product Code Name

Radioimmunoassay, Estradiol

Public Device Record Key

798f232c-49c9-4643-9189-4334916ba93b

Public Version Date

October 19, 2018

Public Version Number

1

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-