Catalog Number

34-2341-11

Brand Name

ImmunoCAP Specific IgE Control L

Version/Model Number

34-2341-11

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

K131738,K131738

Product Code

DHB

Product Code Name

System, test, radioallergosorbent (rast) immunological

Public Device Record Key

88faccf7-d1ea-46a8-902f-474f1b75da7e

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Package DI Number

07333066000930

Quantity per Package

6

Contains DI Package

07333066019949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-