FDA.reportPublic FDA data

EBV IgM Control

Primary DI
B110EBM50300
Brand
EBV IgM Control
Company
Bion Enterprises, Ltd.
Model
EBM-5030
Catalog number
EBM-5030
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
LJNAntibody Igm, If, Epstein-Barr Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJNAntibody Igm, If, Epstein-Barr VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893240000BION EBV-M (VCA) TEST SYSTEMBion Ent., Ltd.1989-07-14LJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110EBM50300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) immunoglobulin M (IgM) 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 M (IgM) antibodies to Epstein-Barr virus (EBV) 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
00847865010801Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJN2023-01-04
B110EB50120Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.LJN2016-09-12
B110EBG50200EBV IgG ControlBion Enterprises, Ltd.LJN2016-09-12
B110EBM1200EBV-VCA IgM Test System, 120 TestsBion Enterprises, Ltd.LJN2016-09-12
B110EBN50100EBV Negative ControlBion Enterprises, Ltd.LJN2016-09-12
00847865000291BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865001236BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865002455BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865011341BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865011358BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00850487007173ReQuest QUEST INTERNATIONAL, INC.LJN2016-08-31
00850487007418SeraQuestQUEST INTERNATIONAL, INC.LJN2016-08-31
00816057020652ASI EB VCA IgM EIA TestARLINGTON SCIENTIFIC, INC.LJN2016-07-08