FDA UDI
In Commercial Distribution
🇺🇸 United States
QUANTA Lite® Calprotectin ELISA
DI: 08426950657484
·
Model: 704770
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- QUANTA Lite® Calprotectin ELISA
- Primary DI
- 08426950657484
- Version / Model
- 704770
- 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
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 98ec0e11-6cb3-421a-aed9-b65b016b64a3
Device Description
1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washing solution (20x): 1x50mL vial. 5. Dilution solution (10x): 1 x20mL vial. 6. Extraction solution (2.5x): 2x50 mL vials. 7. Calibrators: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml). 8. Control 1: 1x1.0 mL vial. 9. Control 2: 1x1.0 mL vial.
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 |
|---|---|---|---|---|
| NXO | Calprotectin, Fecal | Immunology | 866.5180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53624 | Calprotectin 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 calprotectin protein in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is commonly used to aid in the diagnosis of inflammatory bowel disease or other causes of intestinal inflammation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950657484 | GS1 |
Customer Contacts
- Phone
- 1-800-545-9495
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191589 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius