FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747141
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
2327671
Catalog number
2327671
Device description
Captia™ ds/DNA
Published
2016-09-19
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
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923537000ENCORE DS-DNAClark Laboratories, Inc.1992-12-23LRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747141053915167471415391516747141

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) 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 antibodies to double stranded DNA (anti-dsDNA) 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
00840239034380Anti-dsDNA IgG ELISADRG International IncLRM2023-08-24
00840239035646Anti-dsDNA IgM ELISADRG International IncLRM2023-08-24
00840239035653Anti-dsDNA IgA ELISADRG International IncLRM2023-08-24
00840239035660Anti-dsDNA Screen ELISADRG International IncLRM2023-08-24
B3507207000Gold Standard Diagnostics Is-anti-dsDNA ELISA Test KitGold Standard Diagnostics CorporationLRM2022-12-02
04048474034387Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035643Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035650Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035667Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847434385Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435641Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435658Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435665Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-10-27
00816879020014Autostat II Anti-ds-DNAHYCOR BIOMEDICAL LLCLRM2016-09-26
04049016026884Anti-dsDNA-NcX ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLRM2016-09-24
05391516743723Trinity BiotechCLARK LABORATORIES, INC.LRM2016-09-22
00845714001888IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-09-21
00817273020372DiamedixDIAMEDIX CORPORATIONLRM2016-09-20
00847817006937Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817007033Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817007040Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817022364Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817022463Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865000086BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865001342BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12