Catalog Number

A600L2

Brand Name

IMMULITE 2000 rPru av 4 Specific Allergen

Version/Model Number

10471075

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

K132801

Product Code

DHB

Product Code Name

System, test, radioallergosorbent (rast) immunological

Public Device Record Key

c27b8e15-810c-4bd6-ae83-a9b0b4433106

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-