Catalog Number

14-5338-01

Brand Name

ImmunoCAP Allergen g215, Allergen component rPhl p 5b Timothy

Version/Model Number

14-5338-01

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

K111919

Product Code

DHB

Product Code Name

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Public Device Record Key

15d40cf5-3537-4ce1-a9a9-b211753b1cee

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-