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Aptima Trichomonas vaginalis Assay

EUDAMEDFDA 510(k)

Class C (EU MDR)

Ref 303163510(k) K200436Ref 303209

by Hologic

Identity

Trade Name
Aptima Trichomonas vaginalis Assay EUDAMED
Device Name
Aptima Trichomonas vaginalis Assay EUDAMED
Model / Reference
303163 EUDAMED
303209 EUDAMED

Identifiers

Primary DI / UDI-DI
15420045505483 EUDAMED
15420045505513 EUDAMED
Basic UDI-DI
54200455DIAGAPTTRICHWY EUDAMED
Direct Marketing DI
15420045505483 EUDAMED
15420045505513 EUDAMED
510(k) Number
K200436 FDA 510(k)
FDA Product Code
QEP FDA 510(k)
EMDN Code
W0105050310 TRICHOMONAS - NA REAGENTS EUDAMED

Classification

Device Class
Class C EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3393 FDA 510(k)
Regulation Number
866.3393 FDA 510(k)
Market of Registration
Belgium EUDAMED
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Aptima Trichomonas vaginalis Assay by Hologic Inc. — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hologic
EUDAMED SRN
US-MF-000001646
Authorised Representative
Hologic BV BE-AR-000000127

Sources (3)

  • EUDAMED 40ed45d7-7da4-4637-a109-d6ced10890c0 61 fields · synced Jul 20, 2026
  • FDA 510(k) K200436 24 fields · synced May 18, 2026
  • EUDAMED 248b2ec3-f7e0-46d8-9f13-6ab59bb27278 61 fields · synced Jul 20, 2026