Catalog Number

-

Brand Name

Dr. Talbot's

Version/Model Number

1101

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)

Yes

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

f8cbef21-5785-48f5-bab8-8e35ab8622f8

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Package DI Number

20370797011010

Quantity per Package

6

Contains DI Package

00370797011016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-