Catalog Number

04491734160

Brand Name

Elecsys tPSA

Version/Model Number

04491734160

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

Yes

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

P990056,P990056,P990056,P990056

Product Code

MTF

Product Code Name

Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

Public Device Record Key

83efd906-f992-460a-b521-238985561167

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-