FDA.reportPublic FDA data

SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)

Primary DI
05055273216424
Brand
SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)
Company
RANDOX LABORATORIES LIMITED
Model
SR10349
Catalog number
SR10349
Device description
ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2.ToRCH IgM 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 IgM 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
05055273216424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216424050552732164245055273216424

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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05055273200652AMYAY7932AY79322016-09-09
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