FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516746830
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
714623
Catalog number
714623
Device description
Absorbent Solution
Published
2019-12-26
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
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914022000SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSPharmacia Diagnostics, Inc.1992-01-27LFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746830053915167468305391516746830

GMDN Terms#

Term, Definition table
TermDefinition
Immunoglobulin M subclass (IgM subclass) 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 one or multiple immunoglobulin M subclasses (IgM subclasses) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume12Milliliter

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
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
03573026644796VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2026-01-19
04048474028089Varicella Zoster Virus (VZV) IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFY2023-08-29
00840239028082Varicella Zoster Virus (VZV) IgG ELISA DRG International IncLFY2023-08-24
B3507203800Gold Standard Diagnostics Is-VZV IgG ELISA Test KitGold Standard Diagnostics CorporationLFY2020-05-20
05391516746755Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746793Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516743532Trinity BiotechCLARK LABORATORIES, INC.LFY2016-09-23
00817273020228DiamedixDIAMEDIX CORPORATIONLFY2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865010757Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.LFY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
03573026064518VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2016-08-31
00850487007012ReQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00850487007340SeraQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00816057020584ASI VZV IgG EIA TestARLINGTON SCIENTIFIC, INC.LFY2016-07-08