Catalog Number

-

Brand Name

SpermMar IgG Positive Control

Version/Model Number

15518

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

-

Product Code

DFQ

Product Code Name

Sperm, Antigen, Antiserum, Control

Public Device Record Key

58688f74-d8e1-436f-8f5e-c197a90542bd

Public Version Date

April 29, 2020

Public Version Number

2

DI Record Publish Date

April 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-