SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)

Primary DI
05055273216417
Brand
SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)
Company
RANDOX LABORATORIES LIMITED
Model
SR10348
Catalog number
SR10348
Device description
ToRCH IgG Positive Control is intended for use with in vitro assays for determination of IgG antibodies to Cytomegalovirus (CMV), IgG antibodies to Rubella Virus, IgG antibodies to Toxoplasma gondii, IgG antibodies to Herpes Simplex Virus Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Measles Virus, IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori IgG antibodies to Treponema pallidum (Syphilis), IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH IgG Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.ToRCH IgG Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
Published
2020-06-12
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
05055273216417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216417050552732164175055273216417

GMDN Terms#

Term, Definition table
TermDefinition
Multiple infectious organism/newborn TORCH screen 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 immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to organisms in a clinical specimen, as part of an antenatal or newborn infection TORCH screen. The assay is intended to detect infection by multiple organisms that include Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV), Herpes simplex virus 1 (HSV1), Herpes simplex virus 2 (HSV2), human immunodeficiency virus 1 (HIV1), measles virus and/or Treponema pallidum, and sometimes additional organisms.

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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