Catalog Number

443979

Brand Name

BD CTGCTV2

Version/Model Number

443979

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

K210585

Product Code

LSL

Product Code Name

DNA-REAGENTS, NEISSERIA

Public Device Record Key

bdba7331-2d5b-45d3-af0c-ae4a89fb077a

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-