Catalog Number

-

Brand Name

B.R.A.H.M.S KRYPTOR compact PLUS

Version/Model Number

106172

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

DEN150009

Product Code

PMT

Product Code Name

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Public Device Record Key

305620a8-c5bb-4079-985a-b6d08fb0a123

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

August 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-