SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) SR10351

GUDID 05055273216493

Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum. Serology Negative 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 Negative 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
Primary Device ID05055273216493
NIH Device Record Key68abc30b-1b32-4f2b-8082-95555b0053ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)
Version Model NumberSR10351
Catalog NumberSR10351
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

Operating and Storage Conditions

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
GS105055273216493 [Primary]
GS105055273216493 [Primary]

FDA Product Code

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

05055273216493 - SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)2020-05-19Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum. Serology Negative 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 Negative Control is helpful in determining the precision of testing systems and in identifying sources of variation.
05055273216493 - SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)2020-05-19 Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detect
05055273216509 - SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +)2020-05-19 Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Vi
05055273216516 - SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +)2020-05-19 Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Ant
05055273216523 - SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +)2020-05-19 Serology III Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Hepatitis B Core A
05055273216462 - CO2/ELECTROLYTE LINEARITY VERIFIERS (For Roche Systems) (CO2 LIN VER)2020-05-15 CO2/Electrolyte Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Car
05055273216448 - APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems)2020-04-27 Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU
05055273216455 - LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC)2020-04-27 Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for HDL,
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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