Catalog Number

-

Brand Name

BÜHLMANN fCAL® ELISA

Version/Model Number

EK-CAL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NXO

Product Code Name

Calprotectin, Fecal

Public Device Record Key

35529fec-8c64-4ddd-9b7f-182784fdd321

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-