FDA.report

BIOBASE

Primary DI
06971674863397
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:64mL×2 R2:16mL×2
Published
2023-07-21
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
JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971674863397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971674863397069716748633976971674863397

GMDN Terms

TermDefinition
Alpha-hydroxybutyrate dehydrogenase 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 alpha-hydroxybutyrate dehydrogenase 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
06971674863403BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863410BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863427BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
06971674863434BIOBASEBiobase 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