Catalog Number

-

Brand Name

QuantStudio Dx Software V1.0.3, Kit

Version/Model Number

1.0.3

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

K123955

Product Code

OOI

Product Code Name

real time Nucleic acid amplification system

Public Device Record Key

2395d344-bfe8-41fd-ab95-987e117c666b

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-