T3 Uptake 125I RIA 200 Tube Kit - Radioimmunoassay for the quantitative - MP BIOMEDICALS, LLC

Duns Number:137825928

Device Description: Radioimmunoassay for the quantitative determination of T3 Uptake in serum.

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More Product Details

Catalog Number

06B237124

Brand Name

T3 Uptake 125I RIA 200 Tube Kit

Version/Model Number

06B237124

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

-

Product Code Details

Product Code

KHQ

Product Code Name

RADIOASSAY, TRIIODOTHYRONINE UPTAKE

Device Record Status

Public Device Record Key

b4167808-cfe5-4fe3-9063-4aed068ada62

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MP BIOMEDICALS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 36