Aptiva

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 723102

by Inova Diagnostics. Inc.

Identity

Trade Name: Aptiva EUDAMED
Aptiva® CTD Essential Controls EUDAMEDFDA UDI
Generic Name: Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI
Device Name: Aptiva® CTD Essential Controls EUDAMED
1. Aptiva CTD Essential Control 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) 2. Aptiva CTD Essential Control 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) 3. Aptiva CTD Essential Control 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) 4. Aptiva CTD Essential Control 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) FDA UDI
Model / Reference: 723102 EUDAMEDFDA UDI
Description: 1. Aptiva CTD Essential Control 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) 2. Aptiva CTD Essential Control 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) 3. Aptiva CTD Essential Control 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) 4. Aptiva CTD Essential Control 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL) FDA UDI

Identifiers

Primary DI / UDI-DI: 08430793040198 EUDAMEDFDA UDI
Basic UDI-DI: B-08430793040198 EUDAMED
84307930401983Q EUDAMED
FDA Product Code: JJY FDA UDI
EMDN Code: W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
GMDN Term: Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI

Classification

Device Class: Class IVD General EUDAMED
Class B 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

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Aptiva by Inova Diagnostics, Inc. — Class IVD General — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-08430793040198	Class IVD General	Active
EUDAMED	European Union	CE/IVDD	B-08430793040198	Class IVD General	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IVD General	Pending data

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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 (3)

EUDAMED 84ec8317-fc35-422e-9381-b4654a04091b 61 fields · synced Jul 12, 2026
EUDAMED af15c1e7-5bf1-4a83-9023-ff3c92de1cc9 61 fields · synced May 17, 2026
FDA UDI c42460f4-56a1-4412-82b8-dcfadfd1ffb7 35 fields · synced May 29, 2026