FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747103
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
2325861
Catalog number
2325861
Device description
Captia™ EBNA-1 IgM
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K980598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980598000EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.1998-05-01LLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747103053915167471035391516747103

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) immunoglobulin M (IgM) 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 M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

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
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
B110NA51120EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test SystemBion Enterprises, Ltd.LLM2016-09-12
B110NA51400EBNA Positive ControlBion Enterprises, Ltd.LLM2016-09-12