Catalog Number

-

Brand Name

25-Hydroxy Vitamin Ds EIA

Version/Model Number

AC-57SF1

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

K142351

Product Code

MRG

Product Code Name

System, Test, Vitamin D

Public Device Record Key

ac3f6a15-4af2-480e-9f43-8fe1d3a41acf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-