gudid
Primary ID: 9167
a-Gliatest IgA (UDI 9167)
Manufactured by EUROSPITAL SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for a-Gliatest IgA - Primary ID 9167
Device Regulatory Overview
The a-Gliatest IgA (Model/Catalog Number: 9167) is a medical device manufactured by EUROSPITAL SPA. This product is indexed under FDA Product Code / Category Classification MST within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 9167
- Product Code / EMDN
- MST
- Device Name
- 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.
- Database Sync Date
- 2026-08-09 09:05:06
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of a-Gliatest IgA?
The registered manufacturer of record for a-Gliatest IgA is EUROSPITAL SPA.
What is the Primary UDI-DI identifier for a-Gliatest IgA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 9167.
What classification code is assigned to this device?
This device is registered under product classification code MST.
Similar Classification Devices (MST)
Other Devices by EUROSPITAL SPA
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