FDA.reportPublic FDA data

Adenovirus Antigen Substrate, 12 wells, For IFA Test System

Primary DI
B110AD31120
Brand
Adenovirus Antigen Substrate, 12 wells, For IFA Test System
Company
Bion Enterprises, Ltd.
Model
AD-3112
Catalog number
AD-3112
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
GNYAntisera, Fluorescent, Adenovirus 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNYAntisera, Fluorescent, Adenovirus 1-33Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110AD31120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus 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 Adenovirus 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
ENTIADVG00100NovaLisa Adenovirus IgGGold Standard Diagnostics Frankfurt GmbHGNY2024-08-26
ENTIADVG0010NovaLisa Adenovirus IgGGold Standard Diagnostics Frankfurt GmbHGNY2024-08-26
04048474034448Adenovirus Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGNY2023-08-29
04053252286575Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)EMD Millipore CorporationGNY2022-12-01
04053252473166Light Diagnostics ™ SimulFluor® Respiratory Screen KitEMD Millipore CorporationGNY2022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA ReagentEMD Millipore CorporationGNY2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control SlidesEMD Millipore CorporationGNY2022-12-01
04061839705098Light Diagnostics ™ SimulFluor® Respiratory Screen ReagentEMD Millipore CorporationGNY2022-12-01
04053252284311Light Diagnostics ™ Normal Mouse AntibodyEMD Millipore CorporationGNY2022-11-30
04053252407239Light Diagnostics ™ SimulFluor® Respiratory Screen ReagentEMD Millipore CorporationGNY2022-11-30
04053252586392Light Diagnostics ™ Respiratory Screen DFA ReagentEMD Millipore CorporationGNY2022-11-30
04053252624834Light Diagnostics ™ Adenovirus Control SlideEMD Millipore CorporationGNY2022-11-30
04053252627668Light Diagnostics ™ Adenovirus FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-30
04053252789168Light Diagnostics ™ Respiratory Viral Control SlideEMD Millipore CorporationGNY2022-11-30
08436037123078Light Diagnostics ™ Goat Anti-Mouse IgG FITC-Labeled AntibodyEMD Millipore CorporationGNY2022-11-30
04053252322235Light Diagnostics™ SimulFluor® Respiratory Screen KitEMD Millipore CorporationGNY2022-11-29
04053252373411Light Diagnostics ™ Adenovirus Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-29
04053252675546Light Diagnostics ™ Respiratory Viral ScreenEMD Millipore CorporationGNY2022-11-29
04053252362064Light Diagnostics™ Respiratory Panel DFA KitEMD Millipore CorporationGNY2022-11-28
04053252589676Light Diagnostics™ Respiratory Viral Screen IFA KitEMD Millipore CorporationGNY2022-11-28
08436037122651Light Diagnostics™ Respiratory Panel Viral Screening and Identification IFA KitEMD Millipore CorporationGNY2022-11-28
08436037124617Light Diagnostics™ Adenovirus DFA KitEMD Millipore CorporationGNY2022-11-28
08436037124631Light Diagnostics™ Respiratory Panel Viral Screening and Identification DFA KitEMD Millipore CorporationGNY2022-11-28
08436037124914Light Diagnostics™ Respiratory Viral Screen DFA KitEMD Millipore CorporationGNY2022-11-28
00840239034441Adenovirus Antigen (stool) ELISADRG International IncGNY2021-06-07
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2018-07-22