QUANTA Lite® C1q CIC ELISA
Basic Information
- Brand Name
- QUANTA Lite® C1q CIC ELISA
- Primary DI
- 08426950514190
- Version / Model
- 704620
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- cdad20b8-890e-470b-9f8f-1e1e30bd1607
Device Description
1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. C1q CIC ELISA Plate: 12 breakapart 8 well strips coated with human C1q. Each plate is packaged in a re-sealable foil bag containing two desiccant pouch. 4.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use 5.C1q CIC Calibrator A- E: 5 bottles, each containing 1.2mL of diluted aggregated human IgG, with the following concentrations of immune complex: 100, 33.3, 11.1, 3.7, 1.23 microgram Eq/mL. Ready to use. 6. C1q CIC Positive Control: 1 bottle containing 1.2mL of diluted aggregated human IgG. The expected value is given on the QC certificate. Ready to use. 7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use. 8.HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 9. HRP C1q CIC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use. 11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.
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
- No
- 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 |
|---|---|---|---|---|
| DAK | Complement C1q, Antigen, Antiserum, Control | Immunology | 866.5240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54893 | Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative non-specific detection of circulating immune complexes (CIC) in a clinical specimen (i.e., no antibody variable region binding and no specific disease/infection identification), using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950514190 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031563 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius