SpermMar IgG Positive Control - SpermMar IgG Positive Control: Control for use - Fertipro NV

Duns Number:373904101

Device Description: SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG).More information can be found on the FertiPro website: www.fertipro.com

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

SpermMar IgG Positive Control

Version/Model Number

SPMG_P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KTO

Product Code Name

Reagent, Immunoassay, Igg

Device Record Status

Public Device Record Key

1c5366b8-c8b8-41f6-b9dc-d73b800b27c2

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

August 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FERTIPRO NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 34