FDA.reportPublic FDA data

Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test System

Primary DI
B110ME60120
Brand
Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test System
Company
Bion Enterprises, Ltd.
Model
ME-6012
Catalog number
ME-6012
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GREAntiserum, Fluorescent, Rubeola

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GREAntiserum, Fluorescent, RubeolaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110ME60120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Measles virus immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to Measles virus in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-544-5044bion@mblintl.com

Regulatory Flags#

DUNS number
024824641
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
B110AND300I0ANA (HEp-2) Test System, 300 TestsAND-300 IAND-300 I2016-09-12
B110CAL10900ANA CalibratorCAL-1090CAL-10902016-09-12
B110ACA10430ANA ACA ControlACA-1043ACA-10432016-09-12
B110AN10060Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test SystemAN-1006AN-10062016-09-12
B110AN10120Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test SystemAN-1012AN-10122016-09-12
B110AN10160Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test SystemAN-1016AN-10162016-09-12
B110AND1800I0ANA (HEp-2) Test System, 1800 TestsAND-1800 IAND-1800 I2016-09-12
B110ANK1200ANA (HEp-2) Test System, 120 TestsANK-120ANK-1202016-09-12
B110ANK600ANA (HEp-2) Test System, 60 TestsANK-60ANK-602016-09-12
B110ANN10100ANA Negative ControlANN-1010ANN-10102016-09-12
B110ANP10400ANA Homogeneous ControlANP-1040ANP-10402016-09-12
B110NUC10420ANA Nucleolar ControlNUC-1042NUC-10422016-09-12
B110RNP10440ANA RNP ControlRNP-1044RNP-10442016-09-12
B110SCL10460ANA Scl-70 ControlSCL-1046SCL-10462016-09-12
B110SSA10450ANA SSA ControlSSA-1045SSA-10452016-09-12
B110SSB10470ANA SSB ControlSSB-1047SSB-10472016-09-12
B110QRP63140Respiratory Virus Panel Antigen Control Slide, 14 wellsQRP-6314QRP-63142016-09-12
B110QCH41020Chlamydia Antigen Control Slide, 2 wellsQCH-4102QCH-41022016-09-12
B110MUG600Mumps IgG Test System, 60 TestsMUG-60MUG-602016-09-12
B110NA51400EBNA Positive ControlNA-5140NA-51402016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229031001Measles IgG IFA 96 TestHemagen Diagnostics, Inc.GRE2023-10-05
G5229031011Measles IgG IFA Slide Only KitHemagen Diagnostics, Inc.GRE2023-10-05
04053252403323Light Diagnostics ™ Measles Control SlidesEMD Millipore CorporationGRE2022-12-01
04053252475276Light Diagnostics ™ Measles Monoclonal AntibodyEMD Millipore CorporationGRE2022-11-30
04053252783180Light Diagnostics ™ Measles Control SlideEMD Millipore CorporationGRE2022-11-30
04053252283840Light Diagnostics™ Measles IFA KitEMD Millipore CorporationGRE2022-11-28
04049016057222Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057239Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057246Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057253Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057260Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057277Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057284Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057291Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016079422Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
00813545026004Measles IgG 120 Test Kit SCIMEDX CORPORATIONGRE2016-09-21
00813545026028Measles 10 Well; 10 pk SCIMEDX CORPORATIONGRE2016-09-21
B110MEG1200Measles IgG Test System, 120 TestsBion Enterprises, Ltd.GRE2016-09-12
B110MEG60200Measles IgG ControlBion Enterprises, Ltd.GRE2016-09-12
B110MEM1200Measles IgM Test System, 120 TestsBion Enterprises, Ltd.GRE2016-09-12
B110MEM60300Measles IgM ControlBion Enterprises, Ltd.GRE2016-09-12
B110MEN60100Measles Negative ControlBion Enterprises, Ltd.GRE2016-09-12
B110ME60060Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GRE2016-08-02