Catalog Number

-

Brand Name

Hytec Automated EIA System for Total IgE and Specific IgE

Version/Model Number

288-6002-350

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

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

0f1d1b18-c96d-495d-87c9-a1c74b8eeac9

Public Version Date

September 16, 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

-