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Aptiva

EUDAMEDFDA 510(k)FDA UDI

Class IVD General (EU MDR)

Ref 723100510(k) K213403

by Inova Diagnostics. Inc.

Identity

Trade Name
Aptiva EUDAMED
Aptiva® CTD Essential Reagent EUDAMEDFDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI
Device Name
Aptiva® CTD Essential Reagent EUDAMED
1. Aptiva CTD Essential Reagent Cartridge: a. CTD Essential Beads -Synthetic dsDNA antigen -Native RNP antigen -Sm and Ribosomal-P peptides -Recombinant Ro52, Ro60, SSB, Scl-70, Jo-1, Centromere B and DFS70 antigen -Anti-human IgG antigen (goat) -Bovine protein stabilizer b. Assay buffer -Bovine protein stabilizer -Sodium azide c. PE Tracer IgG -Goat anti-human IgG -Bovine protein stabilizer -Sodium azide d. Rehydration buffer Bovine protein stabilizer Sodium azide FDA UDI
Model / Reference
723100 EUDAMEDFDA UDI
Description
1. Aptiva CTD Essential Reagent Cartridge: a. CTD Essential Beads -Synthetic dsDNA antigen -Native RNP antigen -Sm and Ribosomal-P peptides -Recombinant Ro52, Ro60, SSB, Scl-70, Jo-1, Centromere B and DFS70 antigen -Anti-human IgG antigen (goat) -Bovine protein stabilizer b. Assay buffer -Bovine protein stabilizer -Sodium azide c. PE Tracer IgG -Goat anti-human IgG -Bovine protein stabilizer -Sodium azide d. Rehydration buffer Bovine protein stabilizer Sodium azide FDA UDI

Identifiers

Primary DI / UDI-DI
08430793040051 EUDAMEDFDA UDI
Basic UDI-DI
B-08430793040051 EUDAMED
84307930400512R EUDAMED
510(k) Number
K213403 FDA 510(k)FDA UDI
FDA Product Code
LLL FDA 510(k)FDA UDI
OBE FDA UDI
LKP FDA UDI
LKO FDA UDI
LIM FDA UDI
MQA FDA UDI
LSW FDA UDI
EMDN Code
W0102100105,W0102100108,W0102100110,W0102100111,W0102100112,W0102100113,W0102100114,W0102100115,W0102100118,W0102100199 EUDAMED
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class B EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)FDA UDI
864.7455 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

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

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

New Device

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

Aptiva by Inova Diagnostics, Inc. — Class IVD General — IVDR, FDA_510K, IVDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Active

FDA_510K

European Union Active

CE/IVDD

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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 0edd07ba-3524-4075-aaf6-bd06c58c52c9 61 fields · synced Jul 30, 2026
  • FDA 510(k) K213403 24 fields · synced May 18, 2026
  • FDA UDI 6a8bdde4-933e-400c-934a-26c9ab4eeca5 36 fields · synced May 30, 2026
  • EUDAMED 59033c8f-7149-431b-b196-064ff7af3447 61 fields · synced Jul 30, 2026