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Aptiva Celiac Disease IgG Reagent
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 724100510(k) K200230
Identity
- Trade Name
- Aptiva Celiac Disease IgG Reagent EUDAMEDAptiva EUDAMEDAptiva® Celiac Disease IgG Reagent FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex FDA UDI
- Device Name
- Aptiva Celiac Disease IgG Reagent EUDAMEDAptiva® Celiac Disease IgG Reagent EUDAMED1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives FDA UDI
- Model / Reference
- 724100 EUDAMEDFDA UDI
- Description
- 1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793040471 EUDAMEDFDA UDI
- Basic UDI-DI
- 84307930404713K EUDAMEDB-08430793040471 EUDAMED
- 510(k) Number
- K200230 FDA UDI
- FDA Product Code
- MVM FDA UDIMST 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 IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 FDA UDI866.5750 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 IgG Reagent by Inova Diagnostics, Inc. — Class B — FDA_510K, IVDD, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200230 | Class B | Active |
| EUDAMED | European Union | CE/IVDD | 84307930404713K | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 84307930404713K | Class B | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- FDA Applicant
- Inova Diagnostics, Inc.
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED e7010931-a2e9-4aac-9aa1-0cc8cd75417c 85 fields · synced Jun 19, 2026
- EUDAMED 67c0a548-f439-4e41-9048-0e444c2cf1e3 61 fields · synced May 18, 2026
- FDA UDI fc114443-0242-49f3-8666-abeb86f61eaf 36 fields · synced May 30, 2026
- FDA 510(k) K200230 1 fields · synced May 18, 2026