FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274022108
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
TRIS-3U
Device description
TRIGLYCERIDES STANDARD (1x 3mL) Unlabeled Vial
Published
2016-09-12
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274022108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274022108008172740221088172740221080817274022108

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of triglycerides 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
1-305-324-2300customersupport@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817274020425Drew ScientificR12A24D-BUL2016-09-09
00817274021743JAS DiagnosticsA1CC1-0.52016-09-09
00817274021804JAS DiagnosticsLDH2-30R2U2016-09-12
00817274021811JAS DiagnosticsXL-LDH2-402016-09-12
00817274021828JAS DiagnosticsLDH2-120R1U2016-09-12
00817274021835JAS DiagnosticsLDH2-R1-BUL2016-09-12
00817274021842JAS DiagnosticsLDH2-R2-BUL2016-09-12
00817274021859JAS DiagnosticsDG-LDH2-1202016-09-12
00817274021866JAS DiagnosticsLDH2-1202016-09-12
00817274021873JAS DiagnosticsLDH2-1L2016-09-12
00817274020517Drew ScientificDSJ-9001-0012016-09-09
00817274020524DrewDSJ-9001-0212016-09-09
00817274021491JAS DiagnosticsBAS-9001-1812016-09-09
00817274022214JAS DiagnosticsTA1039802016-09-12
00817274022221JAS DiagnosticsTA1035772016-09-12
00817274020692JAS DiagnosticsALP2-1L2016-09-09
00817274020708JAS DiagnosticsXL-ALP2-402016-09-09
00817274020715JAS DiagnosticsALP2-120R1U2016-09-09
00817274020722JAS DiagnosticsALP2-30R2U2016-09-09
00817274020739JAS DiagnosticsALT2-P1L2016-09-09

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Primary DI, Brand, Company table
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00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817039Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
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00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
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14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
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00852676007780Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2020-03-28
00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
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04250317543370Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317543387Serum Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22