FDA.reportPublic FDA data

Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System

Primary DI
B110HS240120
Brand
Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System
Company
Bion Enterprises, Ltd.
Model
HS2-4012
Catalog number
HS2-4012
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
GQOAntisera, Cf, Herpesvirus Hominis 1,2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQOAntisera, Cf, Herpesvirus Hominis 1,2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881261000BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd.1988-06-07GQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110HS240120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/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 G (IgG) and immunoglobulin M (IgM) antibodies to herpes simplex virus 2 (HSV2) 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
8475445044bion@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
05391516743464Trinity BiotechCLARK LABORATORIES, INC.GQO2016-09-23
05391516743495Trinity BiotechCLARK LABORATORIES, INC.GQO2016-09-23
05391516747028Trinity BiotechCLARK LABORATORIES, INC.GQO2016-09-23
05391516747042Trinity BiotechCLARK LABORATORIES, INC.GQO2016-09-23
05700572001614Poly Rb A-Herpes Simplex Virus Type 1AGILENT TECHNOLOGIES SINGAPORE PTE LTDGQO2016-09-16
B110HS130120Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GQO2016-09-12
B110HS1G1200HSV-1 IgG Test System, 120 TestsBion Enterprises, Ltd.GQO2016-09-12
B110HS2G1200HSV-2 IgG Test System, 120 TestsBion Enterprises, Ltd.GQO2016-09-12
B110HSG35200Herpes Simplex IgG ControlBion Enterprises, Ltd.GQO2016-09-12
B110HSM35300Herpes Simplex IgM ControlBion Enterprises, Ltd.GQO2016-09-12
B110HSN35100Herpes Simplex Negative ControlBion Enterprises, Ltd.GQO2016-09-12