Duns Number:373904101
Device Description: Sperm vitality testThe hypo-osmotic swelling test is a sperm vitality test based on the pr Sperm vitality testThe hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell due to the absorption of a hypo-osmotic solution. The HOS test is based on the test procedure described in the WHO laboratory manual for the examination of human semen and sperm-cervical mucus interaction.For more information, visit the FertiPro website: www.fertipro.com
Catalog Number
-
Brand Name
HOS Test
Version/Model Number
HOST
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
25a43ed8-3ada-41f6-b11f-35de07350f77
Public Version Date
February 24, 2021
Public Version Number
1
DI Record Publish Date
February 16, 2021
Package DI Number
05411967000050
Quantity per Package
5
Contains DI Package
05411967001873
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |