FDA.reportPublic FDA data

SpermMar IgG Positive Control

Primary DI
00805360018456
Brand
SpermMar IgG Positive Control
Company
VITROLIFE INC.
Model
15518
Device description
SpermMar IgG Positive Control
Published
2018-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DFQSperm, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFQSperm, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00805360018456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00805360018456008053600184568053600184560805360018456

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.

Regulatory Flags#

DUNS number
051915038
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
00805360016865Enhance Sperm Wash w/ Gentamicin152632018-04-20
00805360018494Enhance Water for Tissue Culture155222018-04-23
00805360014106Handling Pipette155302021-09-03
00805360014113Handling Pipette155312021-09-03
00805360014120Handling Pipette155322021-09-03
00805360014144Handling Pipette155332021-09-03
00805360014151Handling Pipette155342021-09-03
00805360014168Handling Pipette155352021-09-03
00805360014175Handling Pipette155362021-09-03
00805360014182Handling Pipette155372021-09-03
00805360014199Handling Pipette155382021-09-03
10805360014103Handling Pipette155302021-09-03
10805360014110Handling Pipette155312021-09-03
10805360014127Handling Pipette155322021-09-03
10805360014141Handling Pipette155332021-09-03
10805360014158Handling Pipette155342021-09-03
10805360014165Handling Pipette155352021-09-03
10805360014172Handling Pipette155362021-09-03
10805360014189Handling Pipette155372021-09-03
10805360014196Handling Pipette155382021-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474018264Sperm Antibody ELISADRG Instruments Gesellschaft mit beschränkter HaftungDFQ2024-11-22
04048474042498Sperm Antibody ELISADRG Instruments Gesellschaft mit beschränkter HaftungDFQ2023-08-31
00840239042491Sperm Antibody ELISADRG International IncDFQ2023-08-25
00840239018267Sperm Antibody ELISADRG International IncDFQ2023-08-23
00404847418262Sperm Antibody ELISADRG Instruments Gesellschaft mit beschränkter HaftungDFQ2021-06-07
00404847442496Sperm Antibody ELISADRG Instruments Gesellschaft mit beschränkter HaftungDFQ2021-06-07
05400569000841Sperm Antibody ELISADiasource Immunoassays S.A. SADFQ2020-01-09
00805360018388SpermMar IgA Latex ParticlesVITROLIFE INC.DFQ2018-04-23
00805360018432SpermMar IgG Latex ParticlesVITROLIFE INC.DFQ2018-04-23
00805360018449SpermMar IgG Negative ControlVITROLIFE INC.DFQ2018-04-23