Catalog Number

-

Brand Name

Ion PGM™ 318 Dx Chip Kit

Version/Model Number

A18937

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

-

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

PFT

Product Code Name

Reagents for molecular diagnostic test systems

Public Device Record Key

87e6b41e-b4b4-40f8-bbf4-6c9c1631b5e4

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

April 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-