EUROSPITAL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9615139	1000553563	EUROSPITAL S.P.A.	1	N	2026-01-01	VIA FLAVIA 122 TRIESTE IT 34147

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
08028169204055	a-Gliatest IgA - 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 (0, 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.	+3904089971	info@eurospital.it
08028169204062	a-Gliatest IgG - 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.	+3904089971	info@eurospital.it
08028169204079	a-GliaPep IgA - 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 (0, 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.	+3904089971	info@eurospital.it
08028169204086	a-GliaPep IgG - 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (Igg):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 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.	+3904089971	info@eurospital.it
08028169204093	Calprest - 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: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml).8. Control 1: 1x1.0 mL vial.9. Control 2: 1x1.0 mL vial.10. Microtiter plate cover: 1 piece.	+3904089971	info@eurospital.com
08028169204215	PhiCal Test - 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.	800-522-4762	dbosket@gdx.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
18808	1389608502	K191592	CalprestNG, EasyCal	NXO	2019-07-10
18808	1041900003	K191589	Calprest, EasyCal	NXO	2019-07-10
18808	1837506679	K160447	Calprest NG	NXO	2016-11-10
18808	1083192783	K130945	CALPREST	NXO	2014-01-16
18808	1922713612	K113377	GLIADIN IGA AND GLIADIN LGA	MST	2012-12-14
18808	1262959215	K102964	EU-TTG IGA AND EU-TTG IGG	MVM	2011-03-07
18808	1623926746	DEN060001	PHICAL TEST	NXO	2006-04-26
18808	1143504655

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NXO	5	2019-07-10
MST	1	2012-12-14
MVM	1	2011-03-07

PMN#

Calprest, EasyCal

2019-07-10

Eurospital S.p.A.

CalprestNG, EasyCal

2019-07-10

Eurospital S.p.A.

Calprest NG

2016-11-10

EUROSPITAL S.P.A.

CALPREST

2014-01-16

EUROSPITAL S.P.A.

SECURMIX

2000-02-29

EUROSPITAL

GUDID#

EasyCal - 9062

EUROSPITAL SPA

2019-11-05

Calprest NG - 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: 6 vials containing 1.5 ml Calprotectin at six known concentrations (0, 2.5, 12.5, 25, 50 and 150 ng/ml).8. Control 1: 1x1.5 mL vial.9. Control 2: 1x1.5 mL vial.10. Stop Solution: 1x15 mL vial10. Microtiter plate cover: 1 piece.

EUROSPITAL SPA

2016-11-30

PhiCal Test - 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

2016-09-14

Calprest - 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: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml).8. Control 1: 1x1.0 mL vial.9. Control 2: 1x1.0 mL vial.10. Microtiter plate cover: 1 piece.

EUROSPITAL SPA

2016-07-04

a-GliaPep IgG - 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (Igg):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 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

2016-07-04

a-GliaPep IgA - 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 (0, 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

2016-07-04

a-Gliatest IgG - 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

2016-07-04

a-Gliatest IgA - 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 (0, 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

2016-07-04

Eu-tTG IgG - 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):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

2016-07-04

Eu-tTG IgA - 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 (0, 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

2016-07-01