PhiCal Test

GUDID 08028169204215

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.

EUROSPITAL SPA

Calprotectin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08028169204215
• NIH Device Record Key: dc7822c9-a53b-4905-878c-84f4bcd6d918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhiCal Test
• Version Model Number: 9053
• Company DUNS: 429447667
• Company Name: EUROSPITAL SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-522-4762
• Email: dbosket@gdx.net
• Phone: 800-522-4762
• Email: dbosket@gdx.net
• Phone: 800-522-4762
• Email: dbosket@gdx.net
• Phone: 800-522-4762
• Email: dbosket@gdx.net
• Phone: 800-522-4762
• Email: dbosket@gdx.net
• Phone: 800-522-4762
• Email: dbosket@gdx.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08028169204215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN060001

FDA Product Code

• NXO: Calprotectin, Fecal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-14

Devices Manufactured by EUROSPITAL SPA

• 08028169204055 - a-Gliatest IgA: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgA):1x15mL vial. 3. Calibrators: 5 vials containing 1.5
• 08028169204062 - a-Gliatest IgG: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgA):1x15mL vial. 3. Calibrators: 5 vials containing 1.5
• 08028169204079 - a-GliaPep IgA: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgA):1x15mL vial. 3. Calibrators: 5 vials containing 1.5
• 08028169204086 - a-GliaPep IgG: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (Igg):1x15mL vial. 3. Calibrators: 5 vials containing 1.5
• 08028169204093 - Calprest: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washin
• 08028169204215 - PhiCal Test: 2022-06-101. 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.
• 08028169204215 - PhiCal Test: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washin
• 08028169204246 - Calprest NG: 2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washin
• 08028169204710 - EasyCal: 2019-11-13