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) Calprotectin IVD, kit, enzyme immunoassay (EIA) Calprotectin IVD, kit, enzyme immunoassay (EIA) Calprotectin IVD, kit, enzyme immunoassay (EIA) Calprotectin IVD, kit, enzyme immunoassay (EIA) 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