Catalog Number

-

Brand Name

1,25-Dihydroxy Vitamin D EIA

Version/Model Number

AC-62F1

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

K051110

Product Code

MRG

Product Code Name

System, Test, Vitamin D

Public Device Record Key

09a79f15-743b-4233-9da5-ac95c93a10bf

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

-