FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674864066
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:48mL×2 R2:12mL×2
Published
2023-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
06971674864066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674864066069716748640666971674864066

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid 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 uric acid in a clinical specimen.

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22
06971674867272BIOBASER1:60mL×2 R2:20mL×22023-07-24
06971674867289BIOBASER1:18mL×4 R2:6mL×42023-07-24
06971674867296BIOBASER1:18mL×1 R2:6mL×12023-07-24
06971674867302BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867319BIOBASER1:90mL×1 R2:30mL×12023-07-24
06971674867326BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867777BIOBASECalibrator:1mL×12023-07-24

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
06971674864073BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
08806141303077One+Step Uric AcidDFI CO.,LTDKNK2022-10-03