Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash Calprotectin Extraction Buffer FDA UDI
- Generic Name
- Clinical specimen extraction buffer IVD FDA UDI
- Device Name
- QUANTA Flash® Calprotectin Extraction Buffer EUDAMED1. QUANTA Flash Calprotectin Extraction Buffer (2.5X): Two (2) labeled bottles containing 125 mL, concentrated reagent. FDA UDI
- Model / Reference
- 701354 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash Calprotectin Extraction Buffer (2.5X): Two (2) labeled bottles containing 125 mL, concentrated reagent. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950914693 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950914693 EUDAMED
- 510(k) Number
- K170993 FDA UDI
- FDA Product Code
- NXO FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Clinical specimen extraction buffer IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5180 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
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-08426950914693 | 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 c1c141b2-dc7c-49bf-a089-6f615e2352d5 61 fields · synced May 29, 2026
- FDA UDI 919f4e2d-24c9-48cf-a684-0dd3930663c0 36 fields · synced May 29, 2026