FDA.reportPublic FDA data

Alinity

Primary DI
00380740155643
Brand
Alinity
Company
ABBOTT IRELAND
Model
04U0320
Catalog number
04U0320
Device description
Phosphorus2 1120 Tests
Published
2024-03-11
Public version status
New
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
00380740155643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740155643003807401556433807401556430380740155643

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 qualitative and/or quantitative detection of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00811727016249Pointe Phosphorus ReagentHORIBA INSTRUMENTS INCORPORATEDCEO2021-01-30