Catalog Number

SC2500N18-1

Brand Name

SmartCycler Dx System

Version/Model Number

SC2500N18-1

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

K062948

Product Code

NJR

Product Code Name

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Public Device Record Key

b537b656-afce-4faa-b4cd-1f598afd0f1d

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

July 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-