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QUANTA Flash® aCL IgG Reagents

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Flash® aCL IgG Reagents FDA UDI
Generic Name
Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
1. 1 QUANTA Flash aCL IgG Reagent Cartridge 2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 FDA UDI
Model / Reference
701230 FDA UDI
Description
1. 1 QUANTA Flash aCL IgG Reagent Cartridge 2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 FDA UDI

Identifiers

Primary DI / UDI-DI
08426951289295 FDA UDI
510(k) Number
K092181 FDA UDI
FDA Product Code
MID FDA UDI
GMDN Term
Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay

QUANTA Flash® aCL IgG Reagents by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K092181 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI 6617273e-63d7-4e5a-b8e7-3ad2dc32799d 36 fields · synced May 30, 2026