Catalog Number

-

Brand Name

TriniCLOT Lupus Screen

Version/Model Number

T1604

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

K000527,K000527

Product Code

GIR

Product Code Name

Reagent, Russel Viper Venom

Public Device Record Key

36fd54f2-23cb-43ec-b72a-ee6ec7550efa

Public Version Date

July 08, 2019

Public Version Number

1

DI Record Publish Date

June 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-