Catalog Number

34-2271-61

Brand Name

ImmunoCAP Specific IgE Conjugate 100

Version/Model Number

34-2271-61

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

K051218,K051218

Product Code

DHB

Product Code Name

System, test, radioallergosorbent (rast) immunological

Public Device Record Key

44a9e987-3b12-440a-9d11-04eb29f771cc

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 28, 2019

Package DI Number

07333066000183

Quantity per Package

6

Contains DI Package

07333066019758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-