FDA.reportPublic FDA data

LIQUID RANBUT (RBT)

Primary DI
05055273215571
Brand
LIQUID RANBUT (RBT)
Company
RANDOX LABORATORIES LIMITED
Model
RB8378
Catalog number
RB8378
Device description
For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma.
Published
2022-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
05055273215571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273215571050552732155715055273215571

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate dehydrogenase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of beta-hydroxybutyrate dehydrogenase in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674863397BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
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06971674863410BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JMK2023-07-21
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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
05055273215588LIQUID RANBUT (RBT)RANDOX LABORATORIES LIMITEDJMK2022-09-23
00381931718012PTS Panels® Ketones Test StripsPOLYMER TECHNOLOGY SYSTEMS, INC.JMK2016-09-08