frCRP CP3850

GUDID 05055273201796

The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protein (CRP) concentration in serum or plasma.

RANDOX LABORATORIES LIMITED

C-reactive protein (CRP) IVD, reagent
Primary Device ID05055273201796
NIH Device Record Key7acf2170-e577-4d17-aa84-5a9dc7c4171d
Commercial Distribution Discontinuation2016-09-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NamefrCRP
Version Model NumberCP3850
Catalog NumberCP3850
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
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com
Phone+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273201796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCKC-Reactive Protein, Antigen, Antiserum, And Control

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 Date2016-09-09

On-Brand Devices [frCRP]

05055273201796The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protei
05055273201789The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protei
05055273201772The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protei

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