FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274021057
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
XL-CAA2-40
Device description
CALCIUM ARSENAZO (5 x 40mL)
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
CJYAzo Dye, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJYAzo Dye, CalciumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021057008172740210578172740210570817274021057

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 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
03610230008607Yumizen C1200 Calcium ASHORIBA ABX SASCJY2020-05-06
00380740161491ARCHITECTAbbott GmbHCJY2020-03-09
00380740161507ARCHITECTAbbott GmbHCJY2020-03-09
00380740161514ARCHITECTAbbott GmbHCJY2020-03-09
10758750031795VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJY2019-11-13
05055273208368CALCIUM (Ca)RANDOX LABORATORIES LIMITEDCJY2019-06-03
00386100002060Ca Reagent Kit MEDICA CORPORATIONCJY2019-02-14
00630414220697Atellica CH CA_2Siemens Healthcare Diagnostics Inc.CJY2018-09-24
00380740135409AlinityAbbott GmbHCJY2018-08-31
00380740132613AlinityAbbott GmbHCJY2018-08-08
00817274022450JAS DiagnosticsDREW SCIENTIFIC, INC.CJY2017-04-04
05060500091835Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2017-02-28
00817302023091CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251CAROLINA LIQUID CHEMISTRIES CORPORATIONCJY2016-10-17
15099590000325AUBeckman Coulter, Inc.CJY2016-09-24
15099590011086AUBeckman Coulter, Inc.CJY2016-09-24
15099590060183AUBeckman Coulter, Inc.CJY2016-09-24
00857969006105ACEALFA WASSERMANN, INC.CJY2016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414553160ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo IIISiemens Healthcare Diagnostics Inc.CJY2016-09-24
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EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJY2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJY2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJY2016-09-23
00657498000618Calcium (Arsenazo) LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
00657498001462Sirrus® Calcium LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23