Catalog Number

5056888200

Brand Name

Elecsys BRAHMS PCT

Version/Model Number

5056888200

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

K160729,K173927

Product Code

PMT

Product Code Name

Device to detect and measure procalcitonin (PCT) in human clinical specimens

Public Device Record Key

fc2c2986-b944-459e-9ce7-7c1e0a6fa8ce

Public Version Date

July 17, 2018

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

-