FDA.reportPublic FDA data

RABS

Primary DI
05055273205091
Brand
RABS
Company
RANDOX LABORATORIES LIMITED
Model
RP3857
Catalog number
RP3857
Device description
The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.
Published
2016-09-26
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
JJFAnalyzer, Chemistry, Micro, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJFAnalyzer, Chemistry, Micro, For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024014000RANDOX RX DAYTONARandox Laboratories, Ltd.2003-12-04CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273205091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273205091050552732050915055273205091

GMDN Terms#

Term, Definition table
TermDefinition
Optical instrument calibration/verification solution IVDA reference solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical instrument (e.g., spectrophotometer, nephelometer, microplate reader, real-time PCR instrument). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions of liquid-handling instruments, using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stable on board the analyser for 30 days at approximately 10°C.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+44289445170technical.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
05055273205893RX daytonaRX3900RX39002018-06-07
05055273205947WASH conc. 3RX3946RX39462016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810039380307Cholestech LDX™Alere San Diego, Inc.JJF2023-12-20
00810039380512Cholestech LDX™Alere San Diego, Inc.JJF2023-12-20
05055273205893RX daytonaRANDOX LABORATORIES LIMITEDJJF2018-06-07
00854361008003Alere Cholestech LDX®Alere San Diego, Inc.JJF2018-03-30
03661540600180V-Twin®VitalScientific B.V.JJF2016-11-21
00725609000496SPOTCHECKASTORIA-PACIFIC, INC.JJF2016-10-14
00725609000502SPOTCHECKASTORIA-PACIFIC, INC.JJF2016-10-14
00817439020062Wash Concentrate 1Medtest Dx, Inc.JJF2016-09-27
00817439020079Wash Concentrate 2Medtest Dx, Inc.JJF2016-09-27
00817439020086Wash Concentrate 3Medtest Dx, Inc.JJF2016-09-27
00817439021373MedTest DX Wash Solution for the BS200Medtest Dx, Inc.JJF2016-09-27
05055273205947WASH conc. 3RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273205961ISE DIL URNRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206043WASH conc. 2RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206050WASH conc. 1RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206074Cl SOLNRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206111NSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206289SABSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206982AWSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273210361SOLN WASHRANDOX LABORATORIES LIMITEDJJF2016-09-26
08056771102148LIAISON® XLDIASORIN SPAJJF2016-09-24
00817273020464DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
00817273020471DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
04015630924691cobas 6000 core unitRoche Diagnostics GmbHJJF2016-09-20
04015630924707cobas c 501 ModuleRoche Diagnostics GmbHJJF2016-09-20
04015630925551cobas c 311Roche Diagnostics GmbHJJF2016-09-20
04015630924745COBAS®TaqMan® 48 AnalyzerRoche Molecular Systems, Inc.JJF2014-09-17
04015630925537COBAS® TaqMan®Roche Molecular Systems, Inc.JJF2014-09-15