Catalog Number

4892470160

Brand Name

Elecsys PTH STAT Immunoassay

Version/Model Number

4892470160

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

K070709

Product Code

CEW

Product Code Name

RADIOIMMUNOASSAY, PARATHYROID HORMONE

Public Device Record Key

730e801c-93a2-423f-93dd-181752c500fb

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-