FDA.reportPublic FDA data

Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System

Primary DI
B110CM20120
Brand
Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System
Company
Bion Enterprises, Ltd.
Model
CM-2012
Catalog number
CM-2012
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
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQHAntigen, Cf (Including Cf Control), CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K880679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880679000BION CMV-G TEST SYSTEMBion Ent., Ltd.1988-06-03GQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110CM20120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin M (IgM) 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 M (IgM) antibodies to cytomegalovirus (CMV) 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
G5229021111Cytomegalovirus / CMV IgG IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
G5229021121Cytomegalovirus / CMV IgM IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
04053252589768Light Diagnostics CMV Control Slides (5 pack)EMD Millipore CorporationGQH2020-04-17
04053252671074Light Diagnostics CMV IFA ReagentEMD Millipore CorporationGQH2020-04-17
04053252731730Light Diagnostics Anti-mouse IGG:FITCEMD Millipore CorporationGQH2020-04-17
04053252737183Light Diagnostics Mouse Anti-CMV Monoclonal AntibodyEMD Millipore CorporationGQH2020-04-17
04061841047445Light Diagnostics CMV Control SlideEMD Millipore CorporationGQH2020-04-17
03573026390273ARGENE® CINAkit HCMV ppUL83 USBIOMERIEUX SAGQH2016-10-17
04053252676024Light Diagnostics™ CMV IFA KitEMD Millipore CorporationGQH2016-09-26
00813545025489Cytomegalovirus IgG 120 Tests SCIMEDX CORPORATIONGQH2016-09-20
00813545025502Cytomegalovirus 10wl/10 pk SCIMEDX CORPORATIONGQH2016-09-20
B110CMG1200CMV IgG Test System, 120 TestsBion Enterprises, Ltd.GQH2016-09-12
B110CMG20200CMV IgG ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMM20300CMV IgM ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMN20100CMV Negative ControlBion Enterprises, Ltd.GQH2016-09-12