FDA.reportPublic FDA data

Alinity

Primary DI
00380740158743
Brand
Alinity
Company
ABBOTT IRELAND
Model
04U0930
Catalog number
04U0930
Device description
Uric Acid2 2000 Tests
Published
2022-07-12
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
KNKAcid, uric, uricase (colorimetric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740158743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740158743003807401587433807401587430380740158743

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of uric acid in a clinical specimen, using an enzyme 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
00630414654133Atellica CH UASiemens Healthcare Diagnostics Inc.KNK2026-04-08
08806141304043ONE+Step Uric AcidDFI CO.,LTDKNK2025-09-04
08806141304036ONE+Step Uric AcidDFI CO.,LTDKNK2025-09-03
08806141304029ONE+Step Uric AcidDFI CO.,LTDKNK2025-08-22
00850053916168IDG/SanzayIDG/SANZAY CorporationKNK2024-01-12
10673486002263Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-30
10673486002300Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002317Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002324Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002331Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSKNK2023-11-15
10673486002348Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002355Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSKNK2023-11-15
06971674863908BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863915BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863946BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863960BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863977BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674864011BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674864028BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674864042BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863922BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863939BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863953BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863984BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863991BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864004BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864035BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864059BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864066BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864073BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13