Catalog Number

LCGZ4

Brand Name

IMMULITE®/IMMULITE® 1000 Systems HCG Sample Diluent

Version/Model Number

10386978

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

K990222

Product Code

DHA

Product Code Name

SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Public Device Record Key

3b7e60bb-f974-4cf8-8650-ab2f6ee52d6f

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

-