Catalog Number

-

Brand Name

7500 Fast Dx Real-Time PCR  Instrument

Version/Model Number

7503

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

-

Product Code

NSU

Product Code Name

Instrumentation for clinical multiplex test systems

Public Device Record Key

e83f638d-1757-468a-8966-d7890f39bd40

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-