Catalog Number

25000040

Brand Name

FastPack® IP Total PSA Kit (30)

Version/Model Number

TPSA Immunoassay

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

K003094,K003094

Product Code

LTJ

Product Code Name

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Public Device Record Key

71c9cf10-55d0-46c7-b5a1-0a9bdf085d88

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-