FDA.reportPublic FDA data

Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System

Primary DI
B110IA11120
Brand
Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System
Company
Bion Enterprises, Ltd.
Model
IA-1112
Catalog number
IA-1112
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
GNSAntisera, Hai, Influenza Virus A, B, C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNSAntisera, Hai, Influenza Virus A, B, CMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110IA11120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A 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 influenza A 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
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2019-03-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2018-07-22
30014613330776D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2018-07-22
04049016028284Anti-Influenza A Virus ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016028291Anti-Influenza A Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016028307Anti-Influenza A Virus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016028321Anti-Influenza A/B Virus Pool ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016028338Anti-Influenza B Virus ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016028345Anti-Influenza B Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016028352Anti-Influenza B Virus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
04049016096764Anti-Influenza A/B Virus Pool ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGNS2016-09-24
30014613330752D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNS2016-09-15
B110IAG11200Influenza A IgG ControlBion Enterprises, Ltd.GNS2016-09-12
B110IAN11100Influenza A Negative ControlBion Enterprises, Ltd.GNS2016-09-12
B110IB21120Influenza B Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GNS2016-09-12
B110IBG21200Influenza B IgG ControlBion Enterprises, Ltd.GNS2016-09-12
B110IBN21100Influenza B Negative ControlBion Enterprises, Ltd.GNS2016-09-12