Catalog Number

84507

Brand Name

CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel

Version/Model Number

84507

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K823593,K833885,K834526,K843694,K926420,K934524

Product Code

DHB

Product Code Name

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Public Device Record Key

61a2c4e4-ca24-4007-9606-140ecf629e7a

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

-