FDA.report

BIOBASE

Primary DI
06971674863960
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:80mL×2 R2:20mL×2
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KNKAcid, Uric, Uricase (Colorimetric)

Product Code Classifications

CodeDeviceSpecialtyClass
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971674863960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971674863960069716748639606971674863960

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
420046355
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06936895301882BIOBASER1:64mL×2 R2:16mL×22023-07-26
06936895301899BIOBASER1:20mL×1 R2:5mL×12023-07-26
06936895301905BIOBASER1:20mL×4 R2:5mL×42023-07-26
06936895301912BIOBASER1:60mL×5 R2:15mL×52023-07-26
06936895301929BIOBASER1:64mL×2 R2:16mL×22023-07-26
06936895301936BIOBASER1:20mL×1 R2:5mL×12023-07-26
06936895301943BIOBASER1:20mL×4 R2:5mL×42023-07-26
06936895301950BIOBASER1:60mL×5 R2:15mL×52023-07-26
06971674862932BIOBASER1:70mL×2 R2:14mL×22023-07-24
06971674862949BIOBASER1:60mL×2 R2:12mL×22023-07-24
06971674862956BIOBASER1:25mL×4 R2:5mL×42023-07-24
06971674862963BIOBASER1:25mL×1 R2:5mL×12023-07-24
06971674862970BIOBASER1:40mL×4 R2:16mL×22023-07-24
06971674862987BIOBASER1:50mL×2 R2:10mL×22023-07-24
06971674862994BIOBASER1:80mL×2 R2:16mL×22023-07-24
06971674863007BIOBASER1:100mL×1 R2:20mL×12023-07-24
06971674863014BIOBASER1:50mL×2 R2:20mL×12023-07-24
06971674863021BIOBASER1:50mL×2 R2:20mL×12023-07-24
06971674863038BIOBASER1:50mL×2 R2:10mL×22023-07-24
06971674863045BIOBASER1:50mL×2 R2:10mL×22023-07-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
08806141303077One+Step Uric AcidDFI CO.,LTDKNK2022-10-03
00817302024173CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212CAROLINA LIQUID CHEMISTRIES CORPORATIONKNK2022-08-19
00817302024258CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT CC212CAROLINA LIQUID CHEMISTRIES CORPORATIONKNK2022-08-19
00817302024418CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT DT212CAROLINA LIQUID CHEMISTRIES CORPORATIONKNK2022-08-19
00817302024555CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT ST212CAROLINA LIQUID CHEMISTRIES CORPORATIONKNK2022-08-19
00380740158378AlinityABBOTT IRELANDKNK2022-07-12
00380740158743AlinityABBOTT IRELANDKNK2022-07-12
00817302024074CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT AU-212CAROLINA LIQUID CHEMISTRIES CORPORATIONKNK2022-07-06
04015630922550Uric Acid ver.2Roche Diagnostics GmbHKNK2021-02-08
00811727015990Pointe Uric Acid ReagentPOINTE SCIENTIFIC, INC.KNK2021-01-30
00811727016294Pointe Uric Acid ReagentPOINTE SCIENTIFIC, INC.KNK2021-01-30
04015630919154Uric Acid ver.2Roche Diagnostics GmbHKNK2021-01-18