Free T4 MAb 125I RIA Kit - Radioimmunoassay for the quantitative - MP BIOMEDICALS, LLC

Duns Number:137825928

Device Description: Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma or serum.

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More Product Details

Catalog Number

06B257215

Brand Name

Free T4 MAb 125I RIA Kit

Version/Model Number

06B257215

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

K823264

Product Code Details

Product Code

CEC

Product Code Name

RADIOIMMUNOASSAY, FREE THYROXINE

Device Record Status

Public Device Record Key

806f9292-a00f-458a-9a5d-adcfb3ac9cc0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2016

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