Identity
- Trade Name
- Aptiva Celiac Disease IgA Control EUDAMEDAptiva® Celiac Disease IgA Controls FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, control FDA UDI
- Device Name
- Aptiva Celiac Disease IgA Control EUDAMEDThe Celiac Disease IgA Controls include antibodies to tTG and DGP 1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. FDA UDI
- Model / Reference
- 724122 EUDAMEDFDA UDI
- Description
- The Celiac Disease IgA Controls include antibodies to tTG and DGP 1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793040587 EUDAMEDFDA UDI
- Basic UDI-DI
- 843079304058747 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Multiple Coeliac disease-associated antibody IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
No
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
Yes
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 Control by Inova Diagnostics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843079304058747 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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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 (2)
- EUDAMED c5049b0d-7021-481c-8cb6-048f7bd879f0 61 fields · synced Jul 9, 2026
- FDA UDI 615daa8e-5644-4f36-addf-9e57930d4f1b 35 fields · synced May 30, 2026