Catalog Number

85003

Brand Name

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel

Version/Model Number

85003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2017

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

K051677

Product Code

DHB

Product Code Name

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Public Device Record Key

3091c1c7-e253-4619-85e5-8c8f957893a2

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-