FDA.reportPublic FDA data

RSV IgG Control

Primary DI
B110RSG90200
Brand
RSV IgG Control
Company
Bion Enterprises, Ltd.
Model
RSG-9020
Catalog number
RSG-9020
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894623000RESPIRATORY SYNCYTIAL VIRUSBion Ent., Ltd.1989-10-16LKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110RSG90200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to respiratory syncytial virus (RSV) 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
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
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04053252783234Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control SlideEMD Millipore CorporationLKT2022-11-30
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
04053252732294Light Diagnostics™ SimulFluor® RSV/Para 3 DFA KitEMD Millipore CorporationLKT2022-11-28
08436037124624Light Diagnostics™ Respiratory Syncytial Virus DFA KitEMD Millipore CorporationLKT2022-11-28
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05056080501741PathoDx Parainfluenza 3 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
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05056080501765PathoDX Respiratory Mounting FluidREMEL EUROPE LIMITEDLKT2021-07-21
05056080501772PathoDX RVP Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
05056080501789PathoDX RSV Direct SpecimenREMEL EUROPE LIMITEDLKT2021-07-21
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