Catalog Number

8200

Brand Name

QC Sets and Panels: Helix Elite™

Version/Model Number

8200 Cepheid Xpert® C. difficile/Epi Control Panel

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

K190463

Product Code

PMN

Product Code Name

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Public Device Record Key

cb5e6e3c-7dfd-46c0-98e3-8ec0953fc5e5

Public Version Date

August 16, 2019

Public Version Number

2

DI Record Publish Date

May 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-