FDA.reportPublic FDA data

MAGNESIUM Reagent

Primary DI
00628063400799
Brand
MAGNESIUM Reagent
Company
Sekisui Diagnostics, LLC
Model
175-12
Catalog number
175-12
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K111915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111915000MAGNESIUM ASSAYSekisui Diagnostics P.E.I., Inc.2011-12-02JGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400799PrimaryGS10
10628063400796Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400799006280634007996280634007990628063400799
1062806340079610628063400796

GMDN Terms#

Term, Definition table
TermDefinition
Magnesium (Mg2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry method.

Regulatory Flags#

DUNS number
966812344
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100376Acucy Flu Test Kit10102019-08-20
00742860100383Acucy Influenza A&B Control Kit10112019-08-23
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16
00742860000041OSOM COVID-19 Antigen Home Test1067-401067-402024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control Kit10792024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo Home107410742024-12-16
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
00742860100314OSOM Vaginal Transport Swab Set1851852018-04-05
00742860100390OSOM ULTRA PLUS FLU A&B Test10322020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control Kit10342020-06-01
00742860100673OSOM COVID-19 Test109210922026-01-19
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063401291Acetaminophen03R74202023-05-08
00628063401307Acetaminophen Calibrator03R74012023-05-08
00628063401314Alinity c Acetaminophen07P54202023-05-08
00628063401321Alinity c Acetaminophen Calibrator07P54012023-05-08
00628063401222DC-TROL LEVELS 1 & 2SM-0572020-03-30

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