Catalog Number

-

Brand Name

Boditech TSH Calibrator

Version/Model Number

AFIAS-TSHCAL

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

K170232

Product Code

JLW

Product Code Name

Radioimmunoassay, Thyroid-Stimulating Hormone

Public Device Record Key

f7da32a0-7e7f-4721-8e34-5ab3106f4d2b

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-