FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274021880
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
XL-LDL4-40
Device description
LDL, OLYMPUS (4x 40 mL, 2x 45mL)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHMColorimetric Method, Lipoproteins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHMColorimetric Method, LipoproteinsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021880008172740218808172740218800817274021880

GMDN Terms#

Term, Definition table
TermDefinition
LDL (low density lipoprotein) antibody (anti-LDL) 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 detection of antibodies to low density lipoprotein (anti-LDL) 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
06971674861133BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861140BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861157BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861164BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861171BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861188BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861195BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861386BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861393BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861409BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861416BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861423BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861430BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861447BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861454BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861461BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861478BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674861485BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674867760BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
06971674868415BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JHM2023-07-20
00842768020438Dimension Vista® Flex® reagent cartridge HDLCSiemens Healthcare Diagnostics Inc.JHM2020-09-24
00842768022029Dimension® Flex® reagent cartridge AHDLSiemens Healthcare Diagnostics Inc.JHM2020-09-24
00817274022597JAS DiagnosticsDREW SCIENTIFIC, INC.JHM2017-08-21