Pointe Scientific, Inc. - Triglycerides Reagent, for the in vitro - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in ser Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or plasma. Size: 1 x 500 mL

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More Product Details

Catalog Number

13-T7532-500

Brand Name

Pointe Scientific, Inc.

Version/Model Number

13-T7532-500

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

-

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 Details

Product Code

CDT

Product Code Name

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Device Record Status

Public Device Record Key

540eba6f-d1d2-4500-83d2-642f73afe5b8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POINTE SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 455
U Unclassified 2