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
Catalog Number
-
Brand Name
Spermac Stain - Stain A (50ml)
Version/Model Number
SPS050A
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
LED
Product Code Name
Stains, Chemical Solution
Public Device Record Key
535742e6-a291-44d6-9e88-83d5aaf03bf6
Public Version Date
December 10, 2019
Public Version Number
2
DI Record Publish Date
August 22, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |