Catalog Number

04491734160

Brand Name

Elecsys Total PSA Immunoassay

Version/Model Number

04491734160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2018

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

Product Code

MTF

Product Code Name

TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER

Public Device Record Key

e8a2a9cc-151a-48d9-816b-784b4981b6e5

Public Version Date

February 06, 2020

Public Version Number

5

DI Record Publish Date

September 01, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-