Catalog Number

LK3PS1(D)

Brand Name

IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA

Version/Model Number

10706293

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P930027,P930027,P930027,P930027,P930027,P930027,P930027

Product Code

MTF

Product Code Name

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

Public Device Record Key

f45d433d-fb8d-4f6f-ab2a-d470dc405717

Public Version Date

November 18, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-