QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp)
Basic Information
- Brand Name
- QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp)
- Primary DI
- 08426950593560
- Version / Model
- 704605.10L
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c98156d0-adaa-42a8-bb54-2d89f2516a99
Device Description
1. Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use. 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.. 9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid.
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 |
|---|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55223 | Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to tissue transglutaminase (anti-tTG) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950593560 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040466 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius