Aptiva® CTD Essential Calibrators

EUDAMEDFDA 510(k)FDA UDI

Class B (EU MDR)

Ref 723101510(k) K243979

by Inova Diagnostics. Inc.

Identity

Trade Name: Aptiva® CTD Essential Calibrators EUDAMEDFDA UDI
Aptiva EUDAMED
Generic Name: Multiple antinuclear antibody (ANA) screening IVD, calibrator FDA UDI
Device Name: Aptiva® CTD Essential Calibrators EUDAMED
1. Aptiva CTD Essential Calibrator 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 2. Aptiva CTD Essential Calibrator 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 3. Aptiva CTD Essential Calibrator 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 4. Aptiva CTD Essential Calibrator 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 5. Aptiva CTD Essential Calibrator 5 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 6. Aptiva CTD Essential Calibrator 6 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) FDA UDI
Model / Reference: 723101 EUDAMEDFDA UDI
Description: 1. Aptiva CTD Essential Calibrator 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 2. Aptiva CTD Essential Calibrator 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 3. Aptiva CTD Essential Calibrator 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 4. Aptiva CTD Essential Calibrator 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 5. Aptiva CTD Essential Calibrator 5 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) 6. Aptiva CTD Essential Calibrator 6 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL) FDA UDI

Identifiers

Primary DI / UDI-DI: 08430793040181 EUDAMEDFDA UDI
Basic UDI-DI: 843079304018137 EUDAMED
B-08430793040181 EUDAMED
510(k) Number: K243979 FDA 510(k)
FDA Product Code: MSV FDA 510(k)
JIX FDA UDI
EMDN Code: W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
GMDN Term: Multiple antinuclear antibody (ANA) screening IVD, calibrator FDA UDI

Classification

Device Class: Class B EUDAMED
Class IVD General EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 866.5660 FDA 510(k)
Regulation Number: 866.5660 FDA 510(k)
862.1150 FDA UDI
Market of Registration: Italy EUDAMED
Advisory Committee: Immunology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
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® CTD Essential Calibrators by Inova Diagnostics, Inc. — Class B — IVDD, FDA_510K, IVDR — listed in EUDAMED, FDA 510(k), FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Active

FDA_510K

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	843079304018137	Class B	Active
FDA 510(k)	United States	FDA_510K	K243979	Class B	Active
EUDAMED	European Union	CE/IVDR	843079304018137	Class B	Active

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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 (4)

EUDAMED bd37712e-ece3-4593-9f2d-c1d64e876368 61 fields · synced Sep 17, 2026
FDA 510(k) K243979 24 fields · synced May 18, 2026
FDA UDI bb1c59d2-426b-4951-a40b-a44997b7e1ed 35 fields · synced May 30, 2026
EUDAMED 16117c19-fcbb-427c-a503-8ddffc2a9d64 61 fields · synced Sep 17, 2026