FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516743136
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
G5029
Catalog number
G5029
Device description
G6PDH Control, Intermediate
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
KHGWhole Blood Hemoglobin Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHGWhole Blood Hemoglobin DeterminationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K802568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K802568000HEMOGLOBIN CONTROLMarilyn L. Amick1980-11-12KHG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516743136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516743136053915167431365391516743136

GMDN Terms#

Term, Definition table
TermDefinition
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen.

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
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
04048534000840CleanerEKF-diagnostic GmbHKHG2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHKHG2022-12-21
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHKHG2021-05-10
00817869020052Hemoglobin AFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020069Hemoglobin NAFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020076Hemoglobin AF ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020083Hemoglobin AC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020090Hemoglobin AS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020106Hemoglobin AC Control PowderANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020113Hemoglobin F Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020120Hemoglobin F Abnormal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020137Hemoglobin G6PDH Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020144Hemoglobin G6PDH Deficient ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020151Hemoglobin G6PDH Intermediate ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020168Hemoglobin Total Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020175Hemoglobin Total Linearity ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020182Hemoglobin A2 Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020199Hemoglobin A2 Elevated ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020205Hemoglobin AE ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020212Hemoglobin FAS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020229Hemoglobin AD ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020236HemoglobinAG Philadelphia ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00657498000144STAT-Site M Hgb Analyzer PackSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000151STAT-Site M Hgb CardsSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000175STAT-Site M Hgb Code KeySTANBIO LABORATORY, L.P.KHG2016-09-24
05391516743143Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
05391516743150Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
00811727011466Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDKHG2016-08-31
00811727011473Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDKHG2016-08-31