Device
SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class.
Manufacturer
Fertipro NV
Fertipro NV
Model: SPMA_C
DI: 05411967001347
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
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
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a4dfe4dd-e1eb-45b0-bc5f-3eeb58800184
Distribution Status:
In Commercial Distribution
DUNS Number:
373904101
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05411967001347
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 55181
Name: Sperm antibody IVD, reagent
Definition:
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen.
FDA Product Codes
KTO
Reagent, Immunoassay, Igg
Device Sizes
Device Size - Size - @attributes - Unit:
Milliliter
Device Size - Size - @attributes - Value:
0.7
Device Size - Size Type:
Total Volume
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature