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QUANTA Flash® β2GPI IgM Reagents

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Flash® β2GPI IgM Reagents FDA UDI
Generic Name
Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge 2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2 FDA UDI
Model / Reference
701253 FDA UDI
Description
1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge 2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2 FDA UDI

Identifiers

Primary DI / UDI-DI
08426950594475 FDA UDI
510(k) Number
K091556 FDA UDI
FDA Product Code
MSV FDA UDI
GMDN Term
Beta-2-microglobulin 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: Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

QUANTA Flash® β2GPI IgM Reagents by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-2-microglobulin 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 502aa73e-223a-4e69-a960-5f6444439b91 36 fields · synced May 30, 2026