Identity
- Trade Name
- Aptiva Instrument System Cuvettes EUDAMEDAptiva® Instrument System Cuvettes FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Device Name
- Instrument System Cuvettes EUDAMEDThe Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument System Cuvettes are for single use as a reaction or dilution container in the Aptiva Multi-Analyte Instrument. Instrument System Cuvettes are required to ensure the functionality and performance of the Aptiva Multi-Analyte Instrument. Use of alternate cuvettes can negatively impact Aptiva Multi-Analyte Instrument results. FDA UDI
- Model / Reference
- AC1005 EUDAMEDFDA UDI
- Description
- The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument System Cuvettes are for single use as a reaction or dilution container in the Aptiva Multi-Analyte Instrument. Instrument System Cuvettes are required to ensure the functionality and performance of the Aptiva Multi-Analyte Instrument. Use of alternate cuvettes can negatively impact Aptiva Multi-Analyte Instrument results. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195126000741 EUDAMEDFDA UDI
- Basic UDI-DI
- 84307930458034R EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Laboratory analyser cuvette 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aptiva Instrument System Cuvettes 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 | 84307930458034R | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 (2)
- EUDAMED d3939561-f539-4a3c-93f2-bb42c9f90d18 61 fields · synced Jul 24, 2026
- FDA UDI 7ff1983f-fa04-4b0e-ae70-4e858309ff44 34 fields · synced May 30, 2026