Catalog Number

RF412

Brand Name

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge TSH

Version/Model Number

10444911

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112999,K112999

Product Code

CEW

Product Code Name

RADIOIMMUNOASSAY, PARATHYROID HORMONE

Public Device Record Key

58080b06-4710-4443-b122-e3a256d060ce

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-