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 |
|---|---|
| OHQ | Multi-Analyte Controls Unassayed |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05055273216417 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05055273216417 | 05055273216417 | 5055273216417 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +442894451070 | technical.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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