Catalog Number

8297749

Brand Name

VITROS

Version/Model Number

8297749

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

CHI

Product Code Name

LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Public Device Record Key

07c594e0-4bb4-4934-8237-6b8ae3e49be0

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-