FDA.reportPublic FDA data

SPOTCHEM™ II Calcium

Primary DI
00015482771072
Brand
SPOTCHEM™ II Calcium
Company
Arkray USA, Inc.
Model
77107
Device description
Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JGJPHOTOMETRIC METHOD, MAGNESIUM

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015482771072PrimaryGS10
50015482771077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015482771072000154827710720154827710720015482771072
5001548277107750015482771077

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)538-8872xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00015482000011ARK Care®Version 2.5.3.2016-09-23
00015482100025Assure® Slide Pill Swallowing Aid forte10000022018-12-28
00015482100032Assure® Slide Pill Swallowing Aid zero10000032018-12-28
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23

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