Catalog Number

L2HOZ

Brand Name

IMMULITE® 2000 Systems HCY Homocysteine Sample Diluent

Version/Model Number

10387055

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

K003597

Product Code

LPS

Product Code Name

URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

Public Device Record Key

fa92d811-587a-4f70-a9b3-60d46d3ed6ee

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-