Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® aCL IgM Reagents FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- QUANTA Flash® aCL IgM Reagents EUDAMED1. 1 QUANTA Flash aCL IgM Reagent Cartridge 2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2 FDA UDI
- Model / Reference
- 701235 EUDAMEDFDA UDI
- Description
- 1. 1 QUANTA Flash aCL IgM Reagent Cartridge 2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426951289240 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426951289240 EUDAMED
- 510(k) Number
- K092181 FDA UDI
- FDA Product Code
- MID FDA UDI
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
- GMDN Term
- Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 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
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
QUANTA Flash by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426951289240 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 0232ebb5-8f03-4b1f-b17a-e8b9962a0c55 61 fields · synced May 30, 2026
- FDA UDI 13ea856a-2e55-4e74-a6a1-4a77354e340e 36 fields · synced May 30, 2026