SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +) SR10354

GUDID 05055273216523

Serology III Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Hepatitis B Core Antigen (HBc IgM) and IgM antibodies to Hepatitis A (HAV IgM). Serology III Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology III Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.

RANDOX LABORATORIES LIMITED

Multiple blood-borne pathogen antibody/antigen IVD, control Multiple blood-borne pathogen antibody/antigen IVD, control Multiple blood-borne pathogen antibody/antigen IVD, control
Primary Device ID05055273216523
NIH Device Record Keyb1e295a5-0b8d-45e0-aa11-5799bd44bcac
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +)
Version Model NumberSR10354
Catalog NumberSR10354
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273216523 [Primary]
GS105055273216523 [Primary]
GS105055273216523 [Primary]

FDA Product Code

OHQMulti-Analyte Controls Unassayed
OHQMulti-Analyte Controls Unassayed
OHQMulti-Analyte Controls Unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by RANDOX LABORATORIES LIMITED

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05055273216523 - SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +)2020-05-19Serology III Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Hepatitis B Core Antigen (HBc IgM) and IgM antibodies to Hepatitis A (HAV IgM). Serology III Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology III Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
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05055273216479 - BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE)2020-04-27 Bilirubin Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Total and Dir

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