125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators) - A radioimmunoassay for the qualitative - KRONUS, INC.

Duns Number:181070814

Device Description: A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulat A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.

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More Product Details

Catalog Number

KR6160

Brand Name

125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators)

Version/Model Number

KR6160

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

90755f27-7472-450a-a188-bc7753e2813a

Public Version Date

September 24, 2018

Public Version Number

3

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