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QUANTA Flash

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 701247

by Inova Diagnostics. Inc.

Identity

Trade Name
QUANTA Flash EUDAMED
QUANTA Flash® β2GPI IgG Controls FDA UDI
Generic Name
Beta-2-glycoprotein I antibody IVD, control FDA UDI
Device Name
QUANTA Flash® B2GP1 IgG Controls EUDAMED
1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgG High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albumin, stabilizers and preservative. FDA UDI
Model / Reference
701247 EUDAMEDFDA UDI
Description
1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgG High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albumin, stabilizers and preservative. FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595250 EUDAMEDFDA UDI
Basic UDI-DI
B-08426950595250 EUDAMED
510(k) Number
K091556 FDA UDI
FDA Product Code
JJX FDA UDI
EMDN Code
W0102152204 CARDIAC MARKER STANDARDS AND CALIBRATORS EUDAMED
GMDN Term
Beta-2-glycoprotein I antibody IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

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

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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 35c7f5fb-d739-4535-b65a-e79dcf6720f4 61 fields · synced May 30, 2026
  • FDA UDI 3fc1c4a0-aa4a-4bdd-93eb-87571e83c8a9 36 fields · synced May 22, 2026