Identity
- Trade Name
- Aptiva EUDAMEDAptiva Celiac Disease IgG Controls EUDAMEDAptiva® Celiac Disease IgG Controls FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, control FDA UDI
- Device Name
- Aptiva® Celiac Disease IgG Controls EUDAMEDAptiva Celiac Disease IgG Controls EUDAMEDThe Celiac Disease IgG Controls include antibodies to tTG and DGP. 1. Aptiva Celiac IgG 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 IgG 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
- 724102 EUDAMEDFDA UDI
- Description
- The Celiac Disease IgG Controls include antibodies to tTG and DGP. 1. Aptiva Celiac IgG 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 IgG 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
- 08430793040525 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08430793040525 EUDAMED84307930405253H 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 IVD General EUDAMEDClass 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 by Inova Diagnostics, Inc. — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08430793040525 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08430793040525 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED d0110655-8521-4308-b0f2-476cacfcc971 61 fields · synced Aug 2, 2026
- EUDAMED c0f79fc1-b1dd-49fb-b4c8-d86e016b3f86 61 fields · synced May 19, 2026
- FDA UDI def11927-aac5-4e4a-9545-1771c6b03e36 35 fields · synced May 30, 2026