Identity
- Trade Name
- PhiCal Test FDA UDI
- Generic Name
- Calprotectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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: 5 vials containing 1.0 ml Calprotectin at five known concentrations (6.25, 12.5, 25, 50, and 100 ng/ml). 8. Control 1: 1x1.0 mL vial. 9. Control 2: 1x1.0 mL vial. 10. Microtiter plate cover: 1 piece. FDA UDI
- Model / Reference
- 9053 FDA UDI
- 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: 5 vials containing 1.0 ml Calprotectin at five known concentrations (6.25, 12.5, 25, 50, and 100 ng/ml). 8. Control 1: 1x1.0 mL vial. 9. Control 2: 1x1.0 mL vial. 10. Microtiter plate cover: 1 piece. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08028169204215 FDA UDI
- 510(k) Number
- DEN060001 FDA UDI
- FDA Product Code
- NXO FDA UDI
- GMDN Term
- Calprotectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Calprotectin IVD, kit, enzyme immunoassay (EIA)
PhiCal Test by Eurospital — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eurospital
Sources (1)
- FDA UDI dc7822c9-a53b-4905-878c-84f4bcd6d918 36 fields · synced May 30, 2026