FDA.reportPublic FDA data

INORGANIC PHOSPHOROUS (PHOS)

Primary DI
05055273204865
Brand
INORGANIC PHOSPHOROUS (PHOS)
Company
RANDOX LABORATORIES LIMITED
Model
PH3872
Device description
An inorganic phosphorous test system is a device intended for the quantitative in vitro determination of inorganic phosphorous concentration in serum and urine.
Published
2022-10-05
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
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273204865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273204865050552732048655055273204865

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method.

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
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155643AlinityABBOTT IRELANDCEO2024-03-11
00380740155650AlinityABBOTT IRELANDCEO2024-03-11
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00380740155636ARCHITECTABBOTT IRELANDCEO2024-02-26
00850053916120IDG/SanzayIDG/SANZAY CorporationCEO2024-01-12
10673486001976Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC MatrixTECO DIAGNOSTICSCEO2023-11-13
10673486001945Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method)TECO DIAGNOSTICSCEO2023-11-10
10673486001969Teco Diagnostics Inorganic Phosphorus Reagent Set (UV Method)TECO DIAGNOSTICSCEO2023-11-10
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06971674865070BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
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06971674865032BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
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06971674865094BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024272CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT CC218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024432CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT DT218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024579CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT ST218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
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00811727015945Pointe Phosphorus ReagentHORIBA INSTRUMENTS INCORPORATEDCEO2021-01-30
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