FDA.reportPublic FDA data

T BIL

Primary DI
05055273200782
Brand
T BIL
Company
RANDOX LABORATORIES LIMITED
Model
BR2361
Catalog number
BR2361
Device description
The device is intended for the quantitative in vitro determination of total 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
GIGHemoglobinometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIGHemoglobinometerHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973995000RANDOX BILIRUBINRandox Laboratories, Ltd.1997-12-08GIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273200782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273200782050552732007825055273200782

GMDN Terms#

Term, Definition table
TermDefinition
Total 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 total bilirubin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 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
M9308460905110Life InstrumentsLife Instrument CorporationGIG2022-02-25
M93084609051S0Life Instruments Life Instrument CorporationGIG2022-02-25
05055273200799D BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
05055273200812D BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
05055273200829T BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
05055273200836D BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
05055273200843T BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
05055273200850BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
05055273200867BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
00695684782009AIMSTRIP HEMOGLOBIN STARTER KIT 200GERMAINE LABORATORIES, INCGIG2016-05-11