FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516743938
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
2339100
Catalog number
2339100
Device description
Macra® Lp(a)
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
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
JHOElectrophoretic Separation, Lipoproteins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFCLipoprotein, Low-Density, Antigen, Antiserum, ControlImmunology2
JHOElectrophoretic Separation, LipoproteinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971157000MACRALP(A) ENZYME IMMUNOASSAY KITStrategic Diagnostics, Inc.1998-04-15JHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516743938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516743938053915167439385391516743938

GMDN Terms#

Term, Definition table
TermDefinition
Total apolipoprotein IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total apolipoprotein lipid in a clinical specimen, using an enzyme spectrophotometry 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
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
05391516746854Trinity Biotech8274022019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336237380Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237397Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237403Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
08058056680211Lp(a) UltraSENTINEL CH. SPADFC2024-03-15
03607360030073HYDRAGEL LIPO + Lp(a) K20SEBIAJHO2022-12-12
03607360041048HYDRAGEL 7 LIPO + Lp(a)SEBIAJHO2022-12-12
03607360041147HYDRAGEL 7 LIPOPROTEIN(E)SEBIAJHO2022-12-12
03607360041161HYDRAGEL 7 LDL/HDL CHOL DIRECTSEBIAJHO2022-12-12
03607360041246HYDRAGEL 15 LIPO + Lp(a)SEBIAJHO2022-12-12
03607360041352HYDRAGEL 15 LDL/HDL CHOL DIRECTSEBIAJHO2022-12-12
03607360041390HYDRAGEL 30 LDL/HDL CHOL DIRECTSEBIAJHO2022-12-12
03607360041444HYDRAGEL 30 LIPO + Lp(a)SEBIAJHO2022-12-12
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDDFC2022-10-05
00380740170165ARCHITECTABBOTT IRELANDDFC2022-03-16
00380740170158AlinityABBOTT IRELANDDFC2021-05-19
00811727015921Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00811727016225Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00380740175146ARCHITECTAbbott GmbHDFC2020-12-15
07613336140833Tina-quant Lipoprotein (a) Gen.2Roche Diagnostics GmbHDFC2020-03-16
07613336133538Tina-quant Apolipoprotein B ver.2Roche Diagnostics GmbHDFC2020-03-05
00380740156435ARCHITECTABBOTT LABORATORIESDFC2020-03-03
00380740154509AlinityAbbott GmbHDFC2019-09-09
00380740153847AlinityABBOTT LABORATORIESDFC2019-05-10
00896863002318Liposure Serum Lipoprotein Control Level 1 4x0.5mLQUANTIMETRIX CORPORATIONJHO2018-09-26
00896863002325Lipoprint System Buffer 4x16.5gQUANTIMETRIX CORPORATIONJHO2018-09-26
00896863002332Lipoprint LDL Subfractions Kit 4x25 testsQUANTIMETRIX CORPORATIONJHO2018-09-26
00817302022308CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00817302022315CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00630414595559Atellica CH Lp(a)Siemens Healthcare Diagnostics Inc.DFC2017-12-21
M52539000Titan III Lipo (60 x 76 mm)HELENA LABORATORIES CORPORATIONJHO2017-03-17