FDA.reportPublic FDA data

Mumps Virus Antigen Substrate, 12 wells, For IFA Test System

Primary DI
B110MU80120
Brand
Mumps Virus Antigen Substrate, 12 wells, For IFA Test System
Company
Bion Enterprises, Ltd.
Model
MU-8012
Catalog number
MU-8012
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
GRAAntiserum, Fluorescent, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRAAntiserum, Fluorescent, Mumps VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894624000MUMPS VIRUSBion Ent., Ltd.1989-10-16GRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110MU80120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mumps 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 Mumps 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
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
G5229032001Mumps IgG IFA 96 TestHemagen Diagnostics, Inc.GRA2023-10-05
G5229032011Mumps IgG IFA Slide Only KitHemagen Diagnostics, Inc.GRA2023-10-05
04053252364068Light Diagnostics ™ Mumps Control SlidesEMD Millipore CorporationGRA2022-12-01
04053252282713Light Diagnostics ™ Mumps Monoclonal AntibodyEMD Millipore CorporationGRA2022-11-30
04061839704138Light Diagnostics ™ Mumps Control SlideEMD Millipore CorporationGRA2022-11-30
04053252329746Light Diagnostics™ Mumps IFA KitEMD Millipore CorporationGRA2022-11-28
04049016057468Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057475Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057482Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057499Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057505Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057512Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057529Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057536Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016079514Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
00813545026035Mumps IgG 120 Test Kit SCIMEDX CORPORATIONGRA2016-09-21
00813545026059Mumps 10 Well; 10 pk SCIMEDX CORPORATIONGRA2016-09-21
B110MU80060Mumps Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MUG1200Mumps IgG Test System, 120 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG600Mumps IgG Test System, 60 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG80200Mumps IgG ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUM80300Mumps IgM ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUN80100Mumps Negative ControlBion Enterprises, Ltd.GRA2016-09-12