FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674867852
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
Calibrator: 1mL×1
Published
2023-07-22
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
KQNRadioassay, Angiotensin Converting Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQNRadioassay, Angiotensin Converting EnzymeClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674867852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674867852069716748678526971674867852

GMDN Terms#

Term, Definition table
TermDefinition
Angiotensin converting enzyme (ACE) 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 qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) in a clinical specimen.

Sterilization Methods#

Method table
Method

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
EBUHKKACK20BÜHLMANN ACE KineticBühlmann Laboratories AGKQN2025-06-27
08058056685308ACE ReagentSENTINEL CH. SPAKQN2025-01-27
08058056685339ACE ReagentSENTINEL CH. SPAKQN2025-01-27
06971674866831BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674866848BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674866855BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674868361BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
05391516746014Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKQN2016-09-23
EBUHKKACK1ACE Kinetik KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACK21ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACK41ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACKX1ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
08058056681751ACE LiquidSENTINEL CH. SPAKQN2016-07-29