Catalog Number

440483

Brand Name

BD ProbeTec™ ET Lysing Heater, 120v

Version/Model Number

440483

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

K984631

Product Code

LSL

Product Code Name

DNA-REAGENTS, NEISSERIA

Public Device Record Key

b8ccf8e8-0de5-47b1-b14b-50f046ce8427

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-