FDA.reportPublic FDA data

ALB

Primary DI
05055273200034
Brand
ALB
Company
RANDOX LABORATORIES LIMITED
Model
AB3800
Catalog number
AB3800
Device description
An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and 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
CJWBromcresol Purple Dye-Binding, Albumin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000483000RANDOX ALBUMINRandox Laboratories, Ltd.2000-03-31CJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273200034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273200034050552732000345055273200034

GMDN Terms#

Term, Definition table
TermDefinition
Albumin 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 albumin 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
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
05055273205947WASH conc. 3RX3946RX39462016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654003Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2026-03-18
00380740155285AlinityABBOTT IRELANDCJW2024-08-15
00380740155292AlinityABBOTT IRELANDCJW2024-08-15
00380740155483ARCHITECTABBOTT IRELANDCJW2024-08-15
00380740155490ARCHITECTABBOTT IRELANDCJW2024-08-15
08058056681973Albumin BCP (6x20 mL)SENTINEL CH. SPACJW2020-02-24
08058056681980Albumin BCP (6x50 mL)SENTINEL CH. SPACJW2020-02-24
00380740121723AlinityAbbott GmbHCJW2018-07-11
00630414595825Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2017-12-22
00842768005343Dimension® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00842768015021Dimension Vista® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947402ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947419ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.CJW2016-09-23
EABA40000261Piccolo Hepatic Function PanelABAXIS, INC.CJW2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CJW2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CJW2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJW2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJW2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJW2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJW2016-09-23
04015630928064Albumin BCPRoche Diagnostics GmbHCJW2016-09-20
04015630990634AlbuminBCP AlbuminBCPRoche Diagnostics GmbHCJW2016-09-20
00851445007006GENCHEM™ Albumin ReagentGENCHEM INCCJW2016-09-19
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
15099590233341SynchronBeckman Coulter, Inc.CJW2016-08-24
15099590625719SynchronBeckman Coulter, Inc.CJW2016-08-24
00380740012816ARCHITECTABBOTT LABORATORIESCJW2016-06-06