FDA.reportPublic FDA data

SpermMar Test IgG - single kit

Primary DI
05411967002559
Brand
SpermMar Test IgG - single kit
Company
Fertipro NV
Model
SPMG_L
Device 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
Published
2019-12-11
Public version status
Update
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
05411967002559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05411967002559054119670025595411967002559

GMDN Terms#

Term, Definition table
TermDefinition
Sperm antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.

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

Sterilization Methods#

Method table
Method

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
05411967001347SpermMar Test IgA - complete kitSPMA_C2026-05-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05411967001347SpermMar Test IgA - complete kitFertipro NVKTO2026-05-06
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
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