Catalog Number

06B254819

Brand Name

SimulTRAC-S Vitamin B12/Folate 125I RIA Kit

Version/Model Number

06B254819

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

K822728

Product Code

CGN

Product Code Name

ACID, FOLIC, RADIOIMMUNOASSAY

Public Device Record Key

5b8f1b0f-bbea-4c3a-8918-17681f3c853c

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

January 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-