FDA.reportPublic FDA data

Adenovirus IgG Control

Primary DI
B110ADG31200
Brand
Adenovirus IgG Control
Company
Bion Enterprises, Ltd.
Model
ADG-3120
Catalog number
ADG-3120
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B110ADG31200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus 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 Adenovirus 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
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
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