FDA.reportPublic FDA data

JAS Diagnostics, inc

Primary DI
00817274022405
Brand
JAS Diagnostics, inc
Company
DREW SCIENTIFIC, INC.
Model
MAGS-BUL
Catalog number
MAGS-BUL
Device description
Magnesium Standard Liquid Bulk
Published
2017-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JGJPhotometric Method, Magnesium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGJPhotometric Method, MagnesiumClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853592000MAGNESIUMPointe Scientific, Inc.,1985-09-16JGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274022405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274022405008172740224058172740224050817274022405

GMDN Terms#

Term, Definition table
TermDefinition
Magnesium (Mg2+) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of magnesium (Mg2+) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Fahrenheit25 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
305-324-2300customerservice@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
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
10673486002096Teco Diagnostics Magnesium Reagent SetTECO DIAGNOSTICSJGJ2023-11-14
10673486002126Teco Diagnostics Magnesium Reagent Kit for TC-Matrix TECO DIAGNOSTICSJGJ2023-11-14
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024289CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT CC220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024449CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT DT220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024586CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT ST220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00380740169855ARCHITECTABBOTT IRELANDJGJ2022-05-24
00380740169862ARCHITECTABBOTT IRELANDJGJ2022-05-24
00380740176525AlinityABBOTT IRELANDJGJ2021-12-27
00380740176532AlinityABBOTT IRELANDJGJ2021-12-27
04015630913381MagnesiumRoche Diagnostics GmbHJGJ2021-02-08
04015630926992MagnesiumRoche Diagnostics GmbHJGJ2021-02-08
04015630930821Magnesium Gen.2Roche Diagnostics GmbHJGJ2021-02-08
00811727015938Pointe Magnesium ReagentHORIBA INSTRUMENTS INCORPORATEDJGJ2021-01-30
00811727016232Pointe Magnesium Reagent HORIBA INSTRUMENTS INCORPORATEDJGJ2021-01-30
00630414595597Atellica CH MgSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
00842768014185Dimension® Flex® reagent cartridge MGSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
00842768015694Dimension Vista® Flex® reagent cartridge MGSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
03610230007112Yumizen C1200 MagnesiumHORIBA ABX SASJGJ2020-08-28
10758750000265VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGJ2020-05-29
10758750004621VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGJ2020-05-29
07613336121412Magnesium Gen.2Roche Diagnostics GmbHJGJ2020-03-05
07613336169438Magnesium Gen.2Roche Diagnostics GmbHJGJ2019-07-01
05055273204629MAGNESIUM (Mg)RANDOX LABORATORIES LIMITEDJGJ2019-06-03
05055273209303MAGNESIUM (Mg)RANDOX LABORATORIES LIMITEDJGJ2019-06-03
00386100002169Mg Reagent KitMEDICA CORPORATIONJGJ2019-02-14
00380740121839AlinityAbbott GmbHJGJ2019-02-12
00380740121846AlinityAbbott GmbHJGJ2019-02-12
00380740161620ARCHITECTAbbott GmbHJGJ2019-02-05