SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)
Basic Information
- Brand Name
- SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)
- Primary DI
- 05055273216417
- Version / Model
- SR10348
- Catalog Number
- SR10348
- 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
- 2f202017-673f-41a9-aa3f-60f6fe41e5ae
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.
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 | 05055273216417 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius