Catalog Number

-

Brand Name

Specific IgE calibrator set

Version/Model Number

74119

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K941278

Product Code

DHB

Product Code Name

System, Test, Radioallergosorbent (Rast) Immunological

Public Device Record Key

a0667139-6818-469d-b0b9-c694fe1c6ecd

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-