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SpermMar Test IgG antiserum
EUDAMEDFDA UDIClass B (EU MDR)
Ref SPMG_AModel SPMG_S
by FertiPro
Identity
- Trade Name
- SpermMar Test IgG antiserum EUDAMEDSpermMar Test IgG - single kit FDA UDI
- Generic Name
- Sperm antibody IVD, reagent FDA UDI
- Device Name
- SpermMar Test IgG Single kit EUDAMEDSpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of SPMG_A and SPMG_L. The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. 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 FDA UDI
- Model / Reference
- SPMG_S EUDAMEDSPMG_A EUDAMEDFDA UDI
- Description
- SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of SPMG_A and SPMG_L. The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967002542 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967SPMGS135 EUDAMED
- FDA Product Code
- KTO FDA UDI
- EMDN Code
- W0102109013 SPERM ANTIBODIES EUDAMED
- GMDN Term
- Sperm antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5530 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.7 Milliliter FDA UDI
SpermMar Test IgG antiserum by FertiPro — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5411967SPMGS135 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (2)
- EUDAMED 655c8868-409b-4c5c-97c1-c85d4b99fd4f 61 fields · synced Jun 18, 2026
- FDA UDI a90639d3-70af-4b9f-b03e-4d8731d69989 36 fields · synced May 30, 2026