a-Gliatest IgG

GUDID 08028169204062

1. 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.

EUROSPITAL SPA

Gliadin antibody IVD, kit, enzyme immunoassay (EIA) Gliadin antibody IVD, kit, enzyme immunoassay (EIA) Gliadin antibody IVD, kit, enzyme immunoassay (EIA) Gliadin antibody IVD, kit, enzyme immunoassay (EIA) Gliadin antibody IVD, kit, enzyme immunoassay (EIA) Gliadin antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID08028169204062
NIH Device Record Keyd101e206-457a-4af3-96c3-124628a47d84
Commercial Distribution StatusIn Commercial Distribution
Brand Namea-Gliatest IgG
Version Model Number9168
Company DUNS429447667
Company NameEUROSPITAL SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3904089971
Emailinfo@eurospital.it
Phone+3904089971
Emailinfo@eurospital.it
Phone+3904089971
Emailinfo@eurospital.it
Phone+3904089971
Emailinfo@eurospital.it
Phone+3904089971
Emailinfo@eurospital.it
Phone+3904089971
Emailinfo@eurospital.it

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108028169204062 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2016-07-04

Devices Manufactured by EUROSPITAL SPA

08028169204055 - a-Gliatest IgA2022-06-10 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 IgG2022-06-101. 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 IgG2022-06-10 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 IgA2022-06-10 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 IgG2022-06-10 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (Igg):1x15mL vial. 3. Calibrators: 5 vials containing 1.5
08028169204093 - Calprest2022-06-10 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 Test2022-06-10 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 NG2022-06-10 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 - EasyCal2019-11-13

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