Catalog Number

-

Brand Name

N-MID® Osteocalcin ELISA

Version/Model Number

AC-11F1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003609

Product Code

NEO

Product Code Name

System, Test, Osteocalcin

Public Device Record Key

c6b0ea9e-d25c-4137-bcd3-3d6a52ad6626

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

April 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-