SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +) SR10353

GUDID 05055273216516

Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II 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 II 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
Primary Device ID05055273216516
NIH Device Record Keyea55ed63-18c5-47ee-821a-5893e36fe959
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +)
Version Model NumberSR10353
Catalog NumberSR10353
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+4494451070
Emailtechnical.services@randox.com
Phone+4494451070
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
GS105055273216516 [Primary]
GS105055273216516 [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

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