SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)
Basic Information
- Brand Name
- SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -)
- Primary DI
- 05055273216493
- Version / Model
- SR10351
- Catalog Number
- SR10351
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-11
- Public Version
- 2
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 68abc30b-1b32-4f2b-8082-95555b0053ac
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.
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 |
|---|---|---|---|---|
| 64864 | Multiple-type 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 types of 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273216493 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius