Catalog Number

34-2311-12

Brand Name

ImmunoCAP Tryptase Curve Control 1

Version/Model Number

34-2311-12

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

DEN120001,DEN120001

Product Code

OYL

Product Code Name

Tryptase assay system

Public Device Record Key

17df81a9-2e7e-4cb1-9580-3cec8361e217

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 15, 2019

Package DI Number

07333066000275

Quantity per Package

6

Contains DI Package

07333066011998

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-