Catalog Number

95019

Brand Name

CLA-1™ Luminometer

Version/Model Number

95019

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

DHB

Product Code Name

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Public Device Record Key

e6537bc3-1b8e-4a23-9e76-8c5ae234a495

Public Version Date

April 11, 2022

Public Version Number

3

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-