Catalog Number

K3056A

Brand Name

Dimenison Vista Lipase Flex reagent cartridge

Version/Model Number

11538128

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)

-

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

2cf65fae-c432-4aca-917b-d94185b54e45

Public Version Date

November 19, 2021

Public Version Number

2

DI Record Publish Date

November 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-