Catalog Number

34-2274-51

Brand Name

ImmunoCAP Total IgE Curve Control Strip

Version/Model Number

34-2274-51

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

K133404,K133404

Product Code

DGC

Product Code Name

IGE, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

ba87fbf7-f8d9-4d28-8356-804ae5c99fef

Public Version Date

April 05, 2019

Public Version Number

1

DI Record Publish Date

March 28, 2019

Package DI Number

07333066000220

Quantity per Package

5

Contains DI Package

07333066019789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-