QUANTA Flash

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 701148

by Inova Diagnostics. Inc.

Identity

Trade Name: QUANTA Flash EUDAMED
QUANTA Flash® Ro60 Reagents FDA UDI
Generic Name: SSA/Ro antibody (Sjogren's antibody) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name: QUANTA Flash® Ro60 Reagents EUDAMED
1 QUANTA Flash Ro60 Reagent Cartridge 1 Resuspension buffer 1 Transfer pipette FDA UDI
Model / Reference: 701148 EUDAMEDFDA UDI
Description: 1 QUANTA Flash Ro60 Reagent Cartridge 1 Resuspension buffer 1 Transfer pipette FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950595878 EUDAMEDFDA UDI
Basic UDI-DI: B-08426950595878 EUDAMED
510(k) Number: K141328 FDA UDI
FDA Product Code: LLL FDA UDI
EMDN Code: W0102100112 SS-A EUDAMED
GMDN Term: SSA/Ro antibody (Sjogren's antibody) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class: Class IVD General EUDAMED
Class II FDA UDI
Regulation Number: 866.5100 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-08426950595878	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 91aceebf-a353-417c-adb9-ec6378eaad29 61 fields · synced Jun 1, 2026
FDA UDI 2f54ee61-3d8e-42a5-a7d6-0b7643a8cae3 36 fields · synced May 30, 2026