FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274022597
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
LDL4-30
Catalog number
LDL4-30
Device description
LDL, (2 x 30 mL R1, 2 x 10mL R2)
Published
2017-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00817274022597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274022597008172740225978172740225970817274022597

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

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
1-305-324-2300customerservice@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
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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
00817274021880JAS DiagnosticsDREW SCIENTIFIC, INC.JHM2016-09-12