Catalog Number

06B257117

Brand Name

SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit

Version/Model Number

06B257117

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

K822721

Product Code

CDD

Product Code Name

RADIOASSAY, VITAMIN B12

Public Device Record Key

9401150b-c0cf-4d4b-a2df-082b0a88c83d

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

October 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-