FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516744812
Brand
Trinity Biotech
Company
PRIMUS CORPORATION
Model
HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) -
Catalog number
01-04-0018
Device description
Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit
Published
2016-09-06
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
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112015000PREMIER HB9210 HBA1C ANALYZERPrimus Corporation Dba Trinity Biotech2011-11-22LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516744812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516744812053915167448125391516744812

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

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
800-325-3424customerservice@trinityusa.com

Regulatory Flags#

DUNS number
790074793
Device count
1
DM exempt
true
HCT/P
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
05391516748131Trinity BiotechPremier Affinity A1c 1000 - 1 kit09-03-00102016-09-06

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