Catalog Number

8202

Brand Name

QC Sets and Panels: Helix Elite™

Version/Model Number

8202 BD MAX™ Enteric Parasite 20-Day QC 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

K181711

Product Code

PMN

Product Code Name

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

Public Device Record Key

8bfe482e-9977-4fbc-86a3-b55da840f3e1

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

November 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-