QUANTA Flash

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 701248

by Inova Diagnostics. Inc.

Identity

Trade Name: QUANTA Flash EUDAMED
QUANTA Flash® β2GPI IgG Reagents FDA UDI
Generic Name: Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name: QUANTA Flash® B2GP1 IgG Reagents EUDAMED
1. QUANTA Flash β2GP1 IgG Reagent Cartridge 1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2 FDA UDI
Model / Reference: 701248 EUDAMEDFDA UDI
Description: 1. QUANTA Flash β2GP1 IgG Reagent Cartridge 1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2 FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950594420 EUDAMEDFDA UDI
Basic UDI-DI: B-08426950594420 EUDAMED
510(k) Number: K091556 FDA UDI
FDA Product Code: MSV FDA UDI
EMDN Code: W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
GMDN Term: Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class: Class IVD General EUDAMED
Class II FDA UDI
Regulation Number: 866.5660 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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-08426950594420	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 263fa88b-3a4b-4c3e-a2bf-60d98fe7c7d9 61 fields · synced May 30, 2026
FDA UDI 5a6fcb9e-e71f-40d5-b362-cdaa54cf4b8d 36 fields · synced May 30, 2026