FDA.reportPublic FDA data

BIL

Primary DI
05055273200850
Brand
BIL
Company
RANDOX LABORATORIES LIMITED
Model
BR411
Catalog number
BR411
Device description
The device is intended for the quantitative in vitro determination of total and 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
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
05055273200850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273200850050552732008505055273200850

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 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
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
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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
05055273200782T BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
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
05055273200867BILRANDOX LABORATORIES LIMITEDGIG2016-09-16
00695684782009AIMSTRIP HEMOGLOBIN STARTER KIT 200GERMAINE LABORATORIES, INCGIG2016-05-11