FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740161606
Brand
ARCHITECT
Company
Abbott GmbH
Model
3P39-22
Catalog number
03P3922
Device description
Uric Acid
Published
2020-02-29
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
00380740161606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740161606003807401616063807401616060380740161606

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
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
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