Rapid Response - Rapid Response Thyroid Stimulating Hormone Test - BTNX Inc

Duns Number:251005005

Device Description: Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qual Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood.

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More Product Details

Catalog Number

TSH-13C20

Brand Name

Rapid Response

Version/Model Number

TSH-13C20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030912,K030912

Product Code Details

Product Code

JLW

Product Code Name

Radioimmunoassay, Thyroid-Stimulating Hormone

Device Record Status

Public Device Record Key

7faf1112-0890-4223-83a2-ed47af810ea2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BTNX INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 27