Spermac Stain - Stain C (250ml) - Spermac Stain is a qualitative diagnostic kit for - Fertipro NV

Duns Number:373904101

Device Description: Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of staining spermatozoa is to be able to differentiate morphologically normal from abnormal sperm cells.For more information, visit the FertiPro website: www.fertipro.com

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More Product Details

Catalog Number

-

Brand Name

Spermac Stain - Stain C (250ml)

Version/Model Number

SPS250C

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

LED

Product Code Name

Stains, Chemical Solution

Device Record Status

Public Device Record Key

8665a2a1-1cee-41d9-84e4-cd0b979d0ed8

Public Version Date

December 10, 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