FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674863434
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:48mL×2 R2:12mL×2
Published
2023-07-21
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
JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric DehydrogenaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674863434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674863434069716748634346971674863434

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
06936895315780BIOBASEDBI-32026-07-30
06936895300298BIOBASEBK5002023-07-04
06971674861201BIOBASEBK12002023-07-04
06971674861218BIOBASEBK6002023-07-04
06971674861225BIOBASEBK4002023-07-04
06971674861232BIOBASEBK2802023-07-04
06971674861249BIOBASEBK2002023-07-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674863397BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863403BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863410BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863427BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863441BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863458BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863465BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863472BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863489BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863496BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863502BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863519BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
05055273215571LIQUID RANBUT (RBT)RANDOX LABORATORIES LIMITEDJMK2022-09-23
05055273215588LIQUID RANBUT (RBT)RANDOX LABORATORIES LIMITEDJMK2022-09-23
00381931718012PTS Panels® Ketones Test StripsPOLYMER TECHNOLOGY SYSTEMS, INC.JMK2016-09-08