Catalog Number

-

Brand Name

LHsp-IRMA

Version/Model Number

KIP1311

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

-

Product Code

CEP

Product Code Name

RADIOIMMUNOASSAY, LUTEINIZING HORMONE

Public Device Record Key

6851b3c3-75d9-4b28-98cc-1d7cf5eedb55

Public Version Date

October 13, 2020

Public Version Number

1

DI Record Publish Date

October 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-