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QUANTA Flash® aCL IgM Controls

FDA UDI

Class I (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Flash® aCL IgM Controls FDA UDI
Generic Name
Anticardiolipin antibody IVD, control FDA UDI
Device Name
1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum stabilizers and preservative. 2. QUANTA Flash aCL IgM High Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum, stabilizers and preservative. FDA UDI
Model / Reference
701237 FDA UDI
Description
1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum stabilizers and preservative. 2. QUANTA Flash aCL IgM High Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum, stabilizers and preservative. FDA UDI

Identifiers

Primary DI / UDI-DI
08426950594994 FDA UDI
510(k) Number
K092181 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Anticardiolipin antibody IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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, control

QUANTA Flash® aCL IgM Controls by Inova Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 583f82ee-2270-45c6-8212-b35814cb2531 36 fields · synced May 30, 2026