EasyCal

GUDID 08028169204710

EUROSPITAL SPA

Calprotectin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08028169204710
• NIH Device Record Key: bc1198bf-2b16-4f6e-92ff-795840a64072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyCal
• Version Model Number: 9062
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08028169204710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191589

FDA Product Code

• NXO: Calprotectin, Fecal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-13
• Device Publish Date: 2019-11-05

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: 2022-06-10 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
• 08028169204710 - EasyCal: 2019-11-13