FDA.reportPublic FDA data

D BIL

Primary DI
05055273208313
Brand
D BIL
Company
RANDOX LABORATORIES LIMITED
Model
BR8308
Catalog number
BR8308
Device description
The device is intended for the quantitative in vitro determination of direct bilirubin in serum or plasma.
Published
2016-09-16
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
JFMEnzymatic Method, Bilirubin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFMEnzymatic Method, BilirubinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152343000Direct BilirubinRandox Laboratories Limited2016-02-16JFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273208313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273208313050552732083135055273208313

GMDN Terms#

Term, Definition table
TermDefinition
Conjugated (direct) bilirubin 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 conjugated (direct) bilirubin in a clinical specimen.

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
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
05055273214772TOTAL BILIRUBIN 2 (T BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
05055273214796DIRECT BILIRUBIN 2 (D BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
00630414595801Atellica CH DBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-26
00630414595818Atellica CH TBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-21
00630414513058ADVIA® Chemistry Total Bilirubin_2 TBIL_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513065ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513072ADVIA® Chemistry TBIL_2 Total Bilirubin_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513089ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00657498000564Direct Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498000588Total Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498001486Sirrus® Total Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498001493Sirrus® Direct Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
05055273208306T BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208320D BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208337T BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
15099590222642SynchronBeckman Coulter, Inc.JFM2016-08-24