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QUANTA Flash® aCL IgA Reagents

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Flash® aCL IgA Reagents FDA UDI
Generic Name
Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
1 .1 QUANTA Flash aCL IgA Reagent Cartridge 2.1 QUANTA Flash aCL IgA Calibrator 1 3.1 QUANTA Flash aCL IgA Calibrator 2 FDA UDI
Model / Reference
701228 FDA UDI
Description
1 .1 QUANTA Flash aCL IgA Reagent Cartridge 2.1 QUANTA Flash aCL IgA Calibrator 1 3.1 QUANTA Flash aCL IgA Calibrator 2 FDA UDI

Identifiers

Primary DI / UDI-DI
08426950596813 FDA UDI
510(k) Number
K120817 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 IgA 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.

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 7b0e414a-1c65-4ad0-9811-dcb0f82f829d 36 fields · synced Jun 1, 2026