RABS

Basic Information

• Brand Name: RABS
• Primary DI: 05055273205091
• Version / Model: RP3857
• Catalog Number: RP3857
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 7
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: edb607db-40b7-409b-9c53-c663193d634e

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	862.2170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58048	Optical laboratory instrument performance standard calibrator/control IVD, single-use	A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). 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 using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273205091	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K024014	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stable on board the analyser for 30 days at approximately 10°C.
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius