| Primary Device ID | 08028169204062 |
| NIH Device Record Key | d101e206-457a-4af3-96c3-124628a47d84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | a-Gliatest IgG |
| Version Model Number | 9168 |
| 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 |
| Phone | +3904089971 |
| info@eurospital.it | |
| Phone | +3904089971 |
| info@eurospital.it | |
| Phone | +3904089971 |
| info@eurospital.it | |
| Phone | +3904089971 |
| info@eurospital.it | |
| Phone | +3904089971 |
| info@eurospital.it | |
| Phone | +3904089971 |
| info@eurospital.it |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08028169204062 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-07-04 |
| 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 | 2022-06-101. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgA):1x15mL vial. 3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (2, 10, 20, 50 and 100 AU/ml). 4. Control 1: 1x1.5 mL vial. 5. Control 2: 1x1.5 mL vial. 6. Sample Diluent (10x): 1 x20mL vial. 7. Substrate: 1 x15 ml vial. 8. Wash solution (20x): 1x50 mL vial. 9. Stop Solution: 1 x15 ml vial. |
| 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 |