Catalog Number

L2KLH2(D)

Brand Name

IMMULITE 2000 LH Kit Domestic 200T

Version/Model Number

10901863

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K920411

Product Code

CEP

Product Code Name

RADIOIMMUNOASSAY, LUTEINIZING HORMONE

Public Device Record Key

57941181-d681-4278-9c25-ed432d441d5d

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-