Catalog Number

L2UNCVM

Brand Name

IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM

Version/Model Number

10388502

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

K133122

Product Code

JJX

Product Code Name

SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Public Device Record Key

99aca4f1-5905-4094-86b6-466f28abe1b9

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-