FDA.reportPublic FDA data

Alinity

Primary DI
00380740135126
Brand
Alinity
Company
Abbott GmbH
Model
08P4020
Catalog number
08P4020
Device description
Alinity c Phosphorus Reagent Kit 4000 test
Published
2018-07-11
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
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
00380740135126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135126003807401351263807401351260380740135126

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155643AlinityABBOTT IRELANDCEO2024-03-11
00380740155650AlinityABBOTT IRELANDCEO2024-03-11
00380740155629ARCHITECTABBOTT IRELANDCEO2024-02-26
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
06971674865056BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865070BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865087BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865100BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865117BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865124BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865131BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865148BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865155BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865032BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865049BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865063BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865094BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
05055273204865INORGANIC PHOSPHOROUS (PHOS)RANDOX LABORATORIES LIMITEDCEO2022-10-05
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
00817302024098CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT AU-218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-07-06
04015630918973Phosphate (Inorganic) ver.2Roche Diagnostics GmbHCEO2021-05-27
04015630927265Phosphate ver.2Roche Diagnostics GmbHCEO2021-02-08
00811727015945Pointe Phosphorus ReagentHORIBA INSTRUMENTS INCORPORATEDCEO2021-01-30