Catalog Number

10216-4

Brand Name

TRIG Reagent Kit

Version/Model Number

10216-4

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

K080823

Product Code

CDT

Product Code Name

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Public Device Record Key

66b1e977-f72a-4d18-9a74-fdf26ad33c9b

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-