Catalog Number

14-6016-01

Brand Name

ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee

Version/Model Number

14-6016-01

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

-

Product Code

PUW

Product Code Name

System, test, radioallergosorbent (Rast) immunological, exempt allergens

Public Device Record Key

6afcdb4c-28a2-47d0-8d53-e95a5a3460c7

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-