Identity
- Trade Name
- Aptiva® Optical Calibrator Kit EUDAMEDAptiva® Optical Calibrator Kit FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
- Device Name
- Aptiva® Optical Calibrator Kit EUDAMEDAptiva Optical Calibrator Kit is intended to calibrate the Aptiva Multi-Analyte Instrument’s Optical Module (OM). FDA UDI
- Model / Reference
- AC1001 EUDAMEDFDA UDI
- Description
- Aptiva Optical Calibrator Kit is intended to calibrate the Aptiva Multi-Analyte Instrument’s Optical Module (OM). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08430793041126 EUDAMEDFDA UDI
- Basic UDI-DI
- 843079304112636 EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 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
No
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® Optical Calibrator Kit by Inova Diagnostics, Inc. — Class A — 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 | 843079304112636 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 6ca71593-7ed8-4dad-87e4-7c3ab0138942 61 fields · synced Jun 18, 2026
- FDA UDI 7da106a7-cb34-4989-bead-ea7cbd0c1547 35 fields · synced May 27, 2026