RF CAL RF2301

GUDID 05055273205039

This product is intended for in vitro diagnostic use in the calibration of RF on clinical chemistry analysers.

RANDOX LABORATORIES LIMITED

Rheumatoid factor IVD, calibrator
Primary Device ID05055273205039
NIH Device Record Keye5f4984e-e9ce-462c-b674-f7dcee6c553d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRF CAL
Version Model NumberRF2301
Catalog NumberRF2301
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273205039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHRSystem, Test, Rheumatoid Factor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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