Ca CA590

GUDID 05055273200911

The calcium test system is a device intended for the quantitative in vitro determination of calcium in serum, plasma or urine

RANDOX LABORATORIES LIMITED

Calcium (Ca2+) IVD, reagent
Primary Device ID05055273200911
NIH Device Record Keye344f6bf-a8d0-4bbc-9315-4793d22745c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCa
Version Model NumberCA590
Catalog NumberCA590
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

Special Storage Condition, SpecifyBetween 0 and 0 *Stable for 7 days at +2 to +8°C or 3 days at +15 to +25°C once reconstituted.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273200911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CICCresolphthalein Complexone, Calcium

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 Date2016-09-16

On-Brand Devices [Ca]

05055273200928The calcium test system is a device intended for the quantitative in vitro determination of calc
05055273200911The calcium test system is a device intended for the quantitative in vitro determination of calc
05055273200904The calcium test system is a device intended for the quantitative in vitro determination of calc
05055273200898The calcium method used on the Dimension clinical chemistry system is an in vitro diagnostic tes

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