FDA.reportPublic FDA data

SpermMar Test IgA - complete kit

Primary DI
05411967001347
Brand
SpermMar Test IgA - complete kit
Company
Fertipro NV
Model
SPMA_C
Device 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
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTOReagent, Immunoassay, Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTOReagent, Immunoassay, IggImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05411967001347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05411967001347054119670013475411967001347

GMDN Terms#

Term, Definition table
TermDefinition
Sperm antibody IVD, reagentA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.7Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+3250791805info@fertipro.com

Regulatory Flags#

DUNS number
373904101
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05411967000036SpermMar Test IgG - single kitSPMG_S2018-08-22
05411967001354SpermMar Test IgG - Complete kitSPMG_C2019-02-01
05411967002566SpermMar Test IgA - single kitSPMA_S2018-08-22
05411967003464InActiv BlueIB_TUB2024-08-14
05411967003471InActiv BlueIB_TUB2024-08-14
05411967001392SpermFreeze SSPSSP0202020-05-04
05411967001408SpermFreeze SSPSSP1252020-04-30
05411967002023SpermFreeze SSPSSP0012020-05-04
05411967003440SpermFreeze SSPSSP62.52021-07-06
05411967005697SpermFreeze SSPSSP0502023-02-28
05411967000098Sil-Select StockSIS1002016-09-19
05411967001316Sil-Select StockSIS100_322016-09-19
05411967001323Sil-Select StockSIS5002016-09-19
05411967002016SpermFreezeSPF052016-05-24
05411967000869FertiCult Mineral OilMINOIL100P2018-11-06
05411967000883FertiCult Mineral OilMINOIL500P2018-11-06
05411967000890FertiCult Mineral OilMINOIL050P2018-11-06
05411967002009SpermFreezeSPF2016-05-19
05411967000067FertiCult Mineral OilMINOIL050 2016-09-19
05411967000074FertiCult Mineral OilMINOIL1002016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674867609BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867616BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867623BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867630BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867647BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867654BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867661BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867906BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
05411967002542SpermMar Test IgG - single kitFertipro NVKTO2019-12-11
05411967002559SpermMar Test IgG - single kitFertipro NVKTO2019-12-11
05411967001354SpermMar Test IgG - Complete kitFertipro NVKTO2019-02-01
54119670013546SpermMar Test IgG - Complete kitFertipro NVKTO2019-02-01
05411967000036SpermMar Test IgG - single kitFertipro NVKTO2018-08-22
05411967001361SpermMar IgG Negative ControlFertipro NVKTO2018-08-22
05411967001378SpermMar IgG Positive ControlFertipro NVKTO2018-08-22
05411967002566SpermMar Test IgA - single kitFertipro NVKTO2018-08-22
54119670000294SpermMar Test IgA - single kitFertipro NVKTO2018-08-22
54119670000362SpermMar Test IgG - single kitFertipro NVKTO2018-08-22
54119670013614SpermMar IgG Negative ControlFertipro NVKTO2018-08-22
54119670013782SpermMar IgG Positive ControlFertipro NVKTO2018-08-22