FDA.reportPublic FDA data

SpermMar IgG Positive Control

Primary DI
05411967001378
Brand
SpermMar IgG Positive Control
Company
Fertipro NV
Model
SPMG_P
Device description
SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG).More information can be found on the FertiPro website: www.fertipro.com
Published
2018-08-22
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
05411967003181PackageGS11In Commercial Distribution
05411967001378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05411967003181054119670031815411967003181
05411967001378054119670013785411967001378

GMDN Terms#

Term, Definition table
TermDefinition
Sperm antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen.

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
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
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