KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT - An enzyme linked immunosorbent assay for the - KRONUS, INC.

Duns Number:181070814

Device Description: An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.

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More Product Details

Catalog Number

KR7110

Brand Name

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT

Version/Model Number

KR7110

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

871bcf2e-3e3f-4b51-870e-5e0cc452b33c

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