FDA.reportPublic FDA data

RABS

Primary DI
05055273214307
Brand
RABS
Company
RANDOX LABORATORIES LIMITED
Model
RP8398
Catalog number
RP8398
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
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131554000RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTRandox Laboratories, Ltd.2014-01-09JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273214307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273214307050552732143075055273214307

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
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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Primary DI, Brand, Company table
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00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
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