FDA.reportPublic FDA data

SpermMar IgG Negative Control

Primary DI
54119670013614
Brand
SpermMar IgG Negative Control
Company
Fertipro NV
Model
SPMG_N
Device description
SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be fo
Published
2018-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
54119670013614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5411967001361454119670013614

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
54119670013782SpermMar IgG Positive ControlFertipro NVKTO2018-08-22