FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516741859
Brand
Trinity Biotech
Company
TRINITY BIOTECH PUBLIC LIMITED COMPANY
Model
450-100
Catalog number
450-100
Device description
Bile Acid Calibrator 100 umol/l (5 mL)
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872451000BILE ACIDS CALIBRATORSigma Diagnostics, Inc.1987-08-21JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516741859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516741859053915167418595391516741859

GMDN Terms#

Term, Definition table
TermDefinition
Total bile acid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total bile acids in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

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
+35312769800Clinicalchemistry.techsupport@
+35312769800Clinicalchemistry.techsupport@trinitybiotech.com

Regulatory Flags#

DUNS number
988298840
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516741927Trinity Biotech450-A450-A2016-09-23
05391516742238Trinity Biotech591-C591-C2017-10-06
05391516742245Trinity Biotech591-D 591-D 2017-10-06
05391516746106Uni-Gold™ 120650612065062016-09-23
05391516746113Uni-Gold™ 120653012065302016-09-23
05391516742290Trinity Biotech 826-10826-102016-09-23
05391516745161Bartels®B1029-81AB1029-81A2016-09-23
05391516745826Bartels®B1029-44B1029-442016-09-23
05391516745864Bartels® B1029-44CB1029-44C2016-09-23
05391516745871Bartels®B1029-81B1029-812016-09-23
05391516745888Bartels®B1029-81BB1029-81B2016-09-23
05391516745901Bartels®B1029-91B1029-912016-09-23
05391516745918Bartels®B1029-47B1029-472016-09-23
05391516745925Bartels®B1029-47CB1029-47C2016-09-23
05391516745932Bartels®B1029-48B1029-482016-09-23
05391516745949Bartels® B1029-47BB1029-47B2016-09-23
05391516746007MicroTrak®8H219UL8H219UL2016-09-23
05391516746038MicroTrak®8H349UL 8H349UL 2016-09-23
05391516746144MicroTrak®8H399UL8H399UL2016-09-23
05391516748643MicroTrak®8H329UL8H329UL2016-09-23

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Primary DI, Brand, Company table
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14560189216331CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14560189216638CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185395454CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399674CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
00630414611204Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
04015630930609Preciset Lp(a) Gen.2Roche Diagnostics GmbHJIT2025-05-27
10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
10758750032716VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-01-20
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00811403013036Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
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00630414238708DM EXL LOCI BRAHMS PCT Cal KitSiemens Healthcare Diagnostics Inc.JIT2022-11-15
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00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.JIT2021-05-28
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