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Aptiva Celiac Disease IgA Reagent
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 724120
Identity
- Trade Name
- Aptiva Celiac Disease IgA Reagent EUDAMEDAptiva® Celiac Disease IgA Reagent FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex FDA UDI
- Device Name
- Aptiva Celiac Disease IgA Reagent EUDAMED1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives FDA UDI
- Model / Reference
- 724120 EUDAMEDFDA UDI
- Description
- 1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793040532 EUDAMEDFDA UDI
- Basic UDI-DI
- 84307930405323E EUDAMED
- 510(k) Number
- K193604 FDA UDI
- FDA Product Code
- MVM FDA UDIMST FDA UDINSU FDA UDI
- EMDN Code
- W0102100602 TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST EUDAMED
- GMDN Term
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 FDA UDI866.5750 FDA UDI862.2570 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aptiva Celiac Disease IgA Reagent by Inova Diagnostics, Inc. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193604 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 84307930405323E | Class B | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED e30571eb-13c8-47f2-857a-42277c2a5328 61 fields · synced Jul 25, 2026
- FDA UDI 19f31294-1268-4649-af68-774e41da09c2 36 fields · synced May 30, 2026
- FDA 510(k) K193604 1 fields · synced May 18, 2026