FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516744102
Brand
Trinity Biotech
Company
PRIMUS CORPORATION
Model
Ultra2 Genesys Variants Analyzer
Catalog number
03-01-0045
Device description
Hemoglobin variants assay, Ultra2 Genesys Variants Analyzer
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKAAbnormal Hemoglobin Quantitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKAAbnormal Hemoglobin QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955283000PRIMUS VARIANT SYSTEM PVS99Primus Corp.1996-03-01GKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516744102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516744102053915167441025391516744102

GMDN Terms#

Term, Definition table
TermDefinition
Inherited haemoglobinopathy IVD, kit, liquid chromatographyA collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia, using a liquid chromatography method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-325-3424customerservice@trinityusa.com

Regulatory Flags#

DUNS number
790074793
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516749893Trinity BiotechPremier Buffer A Plus Reagent - 940 mL 01-03-00582024-04-12
05391516749909Trinity BiotechPremier Buffer A Plus Reagent - 3.8 L 01-03-00552024-04-12
05391516749916Trinity BiotechPremier Hb9210 HbA1c Analytical Column (1500)09-06-15002024-04-12
05391516749923Trinity BiotechPremier Hb9210 HbA1c Analytical Column (2500)09-06-25002024-04-12
05391516749930Trinity Biotech Premier Hb9210 HbA1c Analytical Column (4000)09-06-40002024-04-12
05391516744379Trinity BiotechHbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 01-04-00152016-09-06
05391516744751Trinity BiotechPremier Hb9210 HbA1c Analyzer - 1 each09-00-00012016-09-06
05391516744768Trinity BiotechPremier Buffer A Reagent - 940mL01-03-00952016-09-06
05391516744775Trinity BiotechPremier Buffer B Reagent - 940mL01-03-00962016-09-06
05391516744782Trinity BiotechPremier Diluent Reagent - 3.8L01-03-00972016-09-06
05391516744799Trinity BiotechPremier Wash Reagent - 940mL01-03-00982016-09-06
05391516744812Trinity BiotechHbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) -01-04-00182016-09-06
05391516748056Trinity BiotechPremier Hb9210 HbA1c Analytical Column (1000)09-06-00462016-09-06
05391516748063Trinity BiotechPremier Hb9210 HbA1c Analytical Column (500)09-06-00502016-09-06
05391516748070Trinity BiotechHbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) -01-04-00222016-09-06
05391516748087Trinity BiotechHbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 01-04-00202016-09-06
05391516748094Trinity BiotechPremier Buffer A Reagent - 3.8L01-03-00802016-09-06
05391516748100Trinity BiotechPremier Buffer B Reagent - 3.8L01-03-00812016-09-06
05391516748117Trinity BiotechPremier Sample Diluent Reagent - 940mL01-03-01012016-09-06
05391516748124Trinity BiotechPremier Affinity A1c 500 - 1 kit09-03-00082016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03607360012444CAPILLARYS 3 DBSSEBIAGKA2024-04-30
03607360025062CAPI 3 NEONAT HbSEBIAGKA2024-04-30
03607360025635CAPI 3 NEONAT HEMOLYSING SOLUTIONSEBIAGKA2024-04-30
03607360025789CAPILLARYS 3 DBS MICROPLATESSEBIAGKA2024-04-30
00847817000560VARIANT nbs Newborn ScreeningBIO-RAD LABORATORIES, INC.GKA2023-01-31
00847817007057Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007064Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007071Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007156Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007170Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007187Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
03607360020074CAPILLARYS HEMOGLOBINSEBIAGKA2018-01-24
03607360022078MINICAP HEMOGLOBINSEBIAGKA2018-01-24
05391516744119Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748179Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748186Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
00847817007354VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008276VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008283VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008306VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008313VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008344VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008351VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
M52551250Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551270Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551280Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
05391516744195Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744201Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744232Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744249Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06