FDA.reportPublic FDA data

EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System

Primary DI
B110NA51120
Brand
EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System
Company
Bion Enterprises, Ltd.
Model
NA-5112
Catalog number
NA-5112
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLMTest, Antigen, Nuclear, Epstein-Barr Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLMTest, Antigen, Nuclear, Epstein-Barr VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894626000EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENBion Ent., Ltd.1989-10-16LLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110NA51120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus nuclear antigen (EBNA) 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 the Epstein-Barr virus nuclear antigen (EBNA) of Epstein-Barr virus (EBV) 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
00840733101953MERIFLUOR EBV-NAMERIDIAN BIOSCIENCE, INC.LLM2020-10-26
05391516746571Bio-Rad PlateliaCLARK LABORATORIES, INC.LLM2019-11-07
05391516743570Trinity BiotechCLARK LABORATORIES, INC.LLM2019-11-05
05391516743587Trinity BiotechCLARK LABORATORIES, INC.LLM2019-11-05
05391516747097Trinity BiotechCLARK LABORATORIES, INC.LLM2019-11-05
05391516747103Trinity BiotechCLARK LABORATORIES, INC.LLM2019-11-05
B110NA51400EBNA Positive ControlBion Enterprises, Ltd.LLM2016-09-12