FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274020920
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
PH6000-UV
Device description
BILIRUBIN CALIBRATOR, 1mL AMPULE GENERIC LABEL
Published
2016-09-09
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274020920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274020920008172740209208172740209200817274020920

GMDN Terms#

Term, Definition table
TermDefinition
Conjugated (direct) bilirubin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of conjugated (direct) bilirubin 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135716ValidateLgc Clinical Diagnostics, Inc.JJY2024-09-05
00852676007087Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007094Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007100Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
03610522248377LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248384LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248391LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248407LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248667LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248674LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248681LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248698LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248872InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248889InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248896InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248902InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31