Catalog Number

14-4508-01

Brand Name

ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase

Version/Model Number

14-4508-01

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

-

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

K072661,K072661

Product Code

JZO

Product Code Name

SYSTEM, TEST, THYROID AUTOANTIBODY

Public Device Record Key

0352aab8-8378-4a4d-93bb-cfd48cfa1ae3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066004020

Quantity per Package

3

Contains DI Package

07333066004013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-