FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp)
DI: 08426950594024
·
Model: 704520.10L
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp)
- Primary DI
- 08426950594024
- Version / Model
- 704520.10L
- 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
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 91d18935-d740-4770-8edf-1d5f3a0c7e46
Device Description
1. 10x Gliadin IgG II ELISA Plate 2. 5x 1.2mL Gliadin IgG II ELISA Low Positive 3. 5x 1.2mL Gliadin IgG II ELISA High Positive 4. 10x 10mL HRP IgG Conjugate 5. 10x 10mL TMB Chromogen 6. 10x 10mL HRP Stop Solution 7. 9 x50mL HRP Sample Diluent 8. 10x 25mL HRP Wash Concentrate, 40x concentrate 9. 5x 1.2mL ELISA Negative Control
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 |
|---|---|---|---|---|
| MST | Antibodies, Gliadin | Immunology | 866.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54947 | Gliadin 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 anti-gliadin antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is intended to be used as an aid in the diagnosis of Coeliac disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950594024 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052142 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius