FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp
DI: 08426950593973
·
Model: 704525.10L
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp
- Primary DI
- 08426950593973
- Version / Model
- 704525.10L
- 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
- 70dffa4b-1f42-4284-8d2a-015d93e43d43
Device Description
1. 10x Gliadin IgA II ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 5x 1.2mL prediluted Gliadin IgA II ELISA High Positive 5. 10x 25mL HRP Wash Concentrate, 40x concentrate 6. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA 7. 10x 10mL TMB Chromogen 8. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid 9. 9x 50mL HRP Sample Diluent
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 | 08426950593973 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052143 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius