SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)
- Primary DI
- 05055273216493
- Brand
- SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)
- Company
- RANDOX LABORATORIES LIMITED
- Model
- SR10351
- Catalog number
- SR10351
- Device description
- Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum.Serology Negative Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.Serology Negative Control is helpful in determining the precision of testing systems and in identifying sources of variation.
- Published
- 2020-05-11
- 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 |
|---|---|---|---|---|
| 05055273216493 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05055273216493 | 05055273216493 | 5055273216493 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple blood-borne pathogen antibody/antigen 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 antibodies to, and antigens from multiple blood-borne pathogens in a clinical specimen. Pathogens detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus, human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2), and Treponema pallidum. |
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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