Duns Number:373904101
Device Description: SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class.The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction.More information can be found at the FertiPro website: www.fertipro.com
Catalog Number
-
Brand Name
SpermMar Test IgA - single kit
Version/Model Number
SPMA_S
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KTO
Product Code Name
Reagent, Immunoassay, Igg
Public Device Record Key
1a3ed3cf-04e2-4658-8b50-fc92a554b8a1
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
August 22, 2018
Package DI Number
05411967000029
Quantity per Package
1
Contains DI Package
05411967002566
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 |