Yumizen C1200 Triglycerides - HORIBA ABX SAS

Duns Number:273647420

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More Product Details

Catalog Number

-

Brand Name

Yumizen C1200 Triglycerides

Version/Model Number

1300023867

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CDT

Product Code Name

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Device Record Status

Public Device Record Key

31dca0a6-1621-41a2-bd25-5b390630bdc0

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HORIBA ABX SAS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 100