MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) - A radioimmunoassay for the quantitative or - KRONUS, INC.

Duns Number:181070814

Device Description: A radioimmunoassay for the quantitative or qualitative determination of antibodies to thy A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.

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More Product Details

Catalog Number

KR6210

Brand Name

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)

Version/Model Number

KR6210

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

JZO

Product Code Name

System, Test, Thyroid Autoantibody

Device Record Status

Public Device Record Key

71d34974-dcff-4f3d-924c-b78713becb54

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KRONUS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24