SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)

Primary DI
05055273216493
Brand
SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)
Company
RANDOX LABORATORIES LIMITED
Model
SR10351
Catalog number
SR10351
Device description
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.
Published
2020-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273216493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216493050552732164935055273216493

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood-borne pathogen antibody/antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to, and antigens from multiple blood-borne pathogens in a clinical specimen. Pathogens detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus, human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2), and Treponema pallidum.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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