Catalog Number

P1-7112

Brand Name

Parainfluenza 1 Virus Antigen Substrate, 12 wells, For IFA Test System

Version/Model Number

P1-7112

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 02, 2020

Issuing Agency

In HIBCC

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

-

Product Code

GQQ

Product Code Name

Antisera, Hai, Parainfluenza Virus 1-4

Public Device Record Key

e86c763e-0d32-4484-ae35-02b8d2d07332

Public Version Date

September 11, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-