Catalog Number

-

Brand Name

25OH Vitamin D Total

Version/Model Number

KAP1971

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

K123364

Product Code

MRG

Product Code Name

SYSTEM, TEST, VITAMIN D

Public Device Record Key

06771f9f-cf42-49b9-ad77-4938cff4f895

Public Version Date

January 10, 2020

Public Version Number

2

DI Record Publish Date

August 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-