SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)

Basic Information

• Brand Name: SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)
• Primary DI: 05055273216424
• Version / Model: SR10349
• Catalog Number: SR10349
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 773b7633-9481-4df0-8937-1e2290793158

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48198	Multiple infectious organism/newborn TORCH screen IVD, control	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273216424	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius