Catalog Number

L2ATC

Brand Name

IMMULITE® 2000 Systems Allergen Tube Caps

Version/Model Number

10282837

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K970227

Product Code

JJE

Product Code Name

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Public Device Record Key

c7a02bdf-ae11-4eee-9822-3bfb29d548d2

Public Version Date

July 26, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-