FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747042
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
2325501
Catalog number
2325501
Device description
Captia™ Herpes Simplex Virus 2 (HSV 2) IgG
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K883281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883281000VIRGO HSV-2 IGG ELISAElectro-Nucleonics, Inc.1989-03-10GQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747042053915167470425391516747042

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
1-800-325-3424Customerservice@trinityusa.com

Regulatory Flags#

DUNS number
623214079
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516746595Immco Diagnostics517551752019-10-25
05391516743914Trinity Biotech233900023390002016-09-19
05391516742276Trinity Biotech805A805A2017-05-07
05391516743938Trinity Biotech233910023391002016-09-23
05391516746533Trinity Biotech5257002019-12-27
05391516747455Trinity Biotech43842402019-12-31
05391516743822Trinity Biotech233817023381702016-09-22
05391516743860Trinity Biotech233857023385702016-09-22
05391516747172Trinity Biotech233857123385712016-09-22
05391516747202Trinity Biotech234698023469802016-09-19
05391516747387BartelsB1029-90CB1029-90C2017-05-07
05391516747394BartelsB1029-90DB1029-90D2017-05-07
05391516743372Trinity Biotech232510023251002016-09-21
05391516746960Trinity Biotech232510123251012016-09-21
05391516746588Bio-StatYY601262019-12-30
05391516747424Phoenix BiotechTS-96-Bulk2019-12-30
05391516747493Immco230AWI2019-12-30
05391516746519Trinity Biotech8271022019-12-27
05391516746526Trinity Biotech9154012019-12-27
05391516746687Bio-Rad72517725172019-12-27

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
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
B110HS240120Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test SystemBion 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